FDA records in 2025
OQRO holds 1,161 FDA records in 2025 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 50 listed companies. GE HealthCare (GEHC) has the most, with 133, ahead of Becton Dickinson (112) and Boston Scientific (92). By kind: 744 recalls, 274 device clearances (510(k)), 133 drug approvals, 10 device approvals (PMA). The busiest month was September, with 124.
- FDA records
- 1,161
- Companies
- 50
- with at least one on file
- Most frequent: kind of action
- Recall
- 744
- Most on file
- GEHC
- GE HealthCare, 133
FDA records per month, 2025
Companies with the most FDA records, 2025
By kind of action, 2025
- Recall744
- Device clearance (510(k))274
- Drug approval133
- Device approval (PMA)10
The most recent FDA records of 2025
Stryker Corporation SYKAction date Dec 31, 2025
Device clearance (510(k)): MOLLI 2 System
510(k) clearance, special: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 30, 2025
Recall, Class II: da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complet…
Medtronic MDTAction date Dec 29, 2025
Device clearance (510(k)): Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheosto…
Filed as Covidien, LLC · 510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Dec 29, 2025
Device clearance (510(k)): Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
Filed as Covidien, LLC · 510(k) clearance, traditional: Substantially Equivalent
Cardinal Health CAHAction date Dec 26, 2025
Recall, Class II: Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Healt…
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/b…
GE HealthCare GEHCAction date Dec 24, 2025
Recall, Class II: GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - ME…
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on t…
Zimmer Biomet ZBHAction date Dec 24, 2025
Recall, Class II: Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: S…
Filed as Zimmer Surgical Inc · Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Zimmer Biomet ZBHAction date Dec 24, 2025
Recall, Class II: Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: S…
Filed as Zimmer Surgical Inc · Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
GE HealthCare GEHCAction date Dec 23, 2025
Device clearance (510(k)): AIR Recon DL
Filed as Ge Medical Systems, LLC · 510(k) clearance, traditional: Substantially Equivalent
Danaher Corporation DHRAction date Dec 23, 2025
Recall, Class II: CellMek SPS Sample Preparation System, REF: C44603, with software
Filed as Beckman Coulter, Inc. · Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample…
Edwards Lifesciences EWAction date Dec 22, 2025
Device approval (PMA): SAPIEN M3 Transcatheter Mitral Valve Replacement System
Premarket approval (PMA): Prosthesis, mitral valve, percutaneously delivered
Johnson & Johnson JNJAction date Dec 22, 2025
Device clearance (510(k)): STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
Filed as ETHICON, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Baxter International BAXAction date Dec 22, 2025
Recall, Class II: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004…
Filed as Baxter Healthcare Corporation · Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Abbott Laboratories ABTAction date Dec 19, 2025
Device approval (PMA): Volt PFA System
Filed as ABBOTT MEDICAL · Premarket approval (PMA): Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Stryker Corporation SYKAction date Dec 19, 2025
Device clearance (510(k)): Hoffmann LRF System
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Dec 19, 2025
Device clearance (510(k)): C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (…
510(k) clearance, traditional: Substantially Equivalent
Eli Lilly LLYAction date Dec 19, 2025
Drug approval: Mounjaro
New use approved (efficacy supplement). Active ingredient: Tirzepatide
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Boston Scientific BSXAction date Dec 19, 2025
Recall, Class I: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
Edwards Lifesciences EWAction date Dec 18, 2025
Device clearance (510(k)): HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
510(k) clearance, traditional: Substantially Equivalent
Abbott Laboratories ABTAction date Dec 18, 2025
Device clearance (510(k)): Assert-IQ (DM5100)
Filed as ABBOTT MEDICAL · 510(k) clearance, special: Substantially Equivalent
AbbVie ABBVAction date Dec 18, 2025
Drug approval: Vraylar
New use approved (efficacy supplement). Active ingredient: Cariprazine Hydrochloride
AbbVie ABBVAction date Dec 18, 2025
Drug approval: Vraylar
New use approved (efficacy supplement). Active ingredient: Cariprazine Hydrochloride
AbbVie ABBVAction date Dec 18, 2025
Drug approval: Vraylar
New use approved (efficacy supplement). Active ingredient: Cariprazine Hydrochloride
AbbVie ABBVAction date Dec 18, 2025
Drug approval: Vraylar
New use approved (efficacy supplement). Active ingredient: Cariprazine Hydrochloride
Abbott Laboratories ABTAction date Dec 17, 2025
Device clearance (510(k)): Amplatzer Piccolo Delivery System (9-PDS-04F-045)
Filed as ABBOTT MEDICAL · 510(k) clearance, traditional: Substantially Equivalent
Dexcom DXCMAction date Dec 17, 2025
Device clearance (510(k)): Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
510(k) clearance, special: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 17, 2025
Device clearance (510(k)): ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L);…
Filed as Ethicon Endo-Surgery, LLC · 510(k) clearance, traditional: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 17, 2025
Drug approval: Rybrevant Faspro
Filed as JANSSEN BIOTECH · Biologic approved. Active ingredient: Amivantamab and Hyaluronidase-Lpuj
Incyte INCYAction date Dec 17, 2025
Drug approval: Zynyz
New use approved (efficacy supplement). Active ingredient: Retifanlimab-Dlwr
Becton Dickinson BDXAction date Dec 17, 2025
Recall, Class II: BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusi…
Filed as CareFusion 213, LLC · Lack of Assurance of Sterlity
Intuitive Surgical ISRGAction date Dec 16, 2025
Device clearance (510(k)): IRISeg
510(k) clearance, traditional: Substantially Equivalent
Baxter International BAXAction date Dec 16, 2025
Device clearance (510(k)): Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Filed as Baxter Healthcare Corporation · 510(k) clearance, traditional: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 15, 2025
Device approval (PMA): ETHIZIA
Filed as ETHICON, Inc. · Premarket approval (PMA): Agent, absorbable hemostatic, collagen with polymeric additives
Stryker Corporation SYKAction date Dec 15, 2025
Device clearance (510(k)): Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Pate…
Filed as Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 15, 2025
Device clearance (510(k)): da Vinci SP Surgical System (SP1098)
510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 15, 2025
Recall, Class II: da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Becton Dickinson BDXAction date Dec 12, 2025
Device clearance (510(k)): EnCor EnCompass Breast Biopsy and Tissue Removal System
Filed as Bard Peripheral Vascular, Inc. · 510(k) clearance, traditional: Substantially Equivalent
Johnson & Johnson JNJAction date Dec 12, 2025
Drug approval: Akeega
Filed as JANSSEN BIOTECH · New use approved (efficacy supplement). Active ingredient: Abiraterone Acetate, Niraparib Tosylate
Viatris VTRSAction date Dec 12, 2025
Drug approval: Octreotide Acetate
Filed as MYLAN LABS LTD · Generic drug approved. Active ingredient: Octreotide Acetate
Merck MRKAction date Dec 12, 2025
Recall, Class II: Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp…
Presence of particulate matter: potential presence of metal particulates in the product.
Becton Dickinson BDXAction date Dec 12, 2025
Recall, Class II: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Filed as Bard Peripheral Vascular Inc · Due to damage to outer tray that can potentially compromise the sterile barrier
Merck MRKAction date Dec 12, 2025
Recall, Class II: Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 0706…
Presence of particulate matter: potential presence of metal particulates in the product.
Stryker Corporation SYKAction date Dec 11, 2025
Device clearance (510(k)): Target Detachable Coil
510(k) clearance, traditional: Substantially Equivalent
GE HealthCare GEHCAction date Dec 10, 2025
Recall, Class II: SMV DSI, System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter)…
GE HealthCare GEHCAction date Dec 10, 2025
Recall, Class II: SMV BodyTrack, System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter)…
GE HealthCare GEHCAction date Dec 10, 2025
Recall, Class II: SMV DSX New Line, System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter)…
Medtronic MDTAction date Dec 10, 2025
Recall, Class II: Mazor X robotic guidance system REF: TPL0059
Filed as Mazor Robotics Ltd · Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
GE HealthCare GEHCAction date Dec 10, 2025
Recall, Class II: MAXXUS, System, Tomography, Computed, Emission
Filed as GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter)…
GE HealthCare GEHCAction date Dec 9, 2025
Device clearance (510(k)): Allia Moveo
Filed as GE Medical Systems SCS · 510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 4…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog N…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 4…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical ISRGAction date Dec 9, 2025
Recall, Class II: Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/C…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Danaher Corporation DHRAction date Dec 8, 2025
Recall, Class II: The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipopr…
Filed as Beckman Coulter Ireland, Inc. · Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceri…
Keurig Dr Pepper KDPAction date Dec 6, 2025
Recall, Class II: McCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keuri…
Product is labeled as decaf, but might contain caffeine.
Thermo Fisher Scientific TMOAction date Dec 5, 2025
Device clearance (510(k)): Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
510(k) clearance, traditional: Substantially Equivalent
ResMed| RMDAction date Dec 5, 2025
Device clearance (510(k)): Personalized Therapy Comfort Settings (PTCS)
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Dec 4, 2025
Recall, Class II: Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14…
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Intuitive Surgical ISRGAction date Dec 4, 2025
Recall, Class II: Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Descriptio…
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Johnson & Johnson JNJAction date Dec 4, 2025
Recall, Class II: Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Filed as Abiomed, Inc. · Device packaged in incorrect outer box carton.
Insulet Corporation PODDAction date Dec 3, 2025
Device clearance (510(k)): Omnipod 5 algorithm
510(k) clearance, traditional: Substantially Equivalent
Medtronic MDTAction date Dec 3, 2025
Device clearance (510(k)): Hugo RAS System
Filed as Covidien, LLC · 510(k) clearance, traditional: Substantially Equivalent
Viatris VTRSAction date Dec 3, 2025
Drug approval: Macitentan
Filed as MYLAN · Generic drug approved. Active ingredient: Macitentan
Boston Scientific BSXAction date Dec 3, 2025
Recall, Class II: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.…
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation…
Becton Dickinson BDXAction date Dec 3, 2025
Recall, Class II: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01…
Filed as CareFusion 303, Inc. · Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Medtronic MDTAction date Dec 3, 2025
Recall, Class II: A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and oper…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Becton Dickinson BDXAction date Dec 2, 2025
Device clearance (510(k)): 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
510(k) clearance, traditional: Substantially Equivalent
Intuitive Surgical ISRGAction date Dec 2, 2025
Device clearance (510(k)): da Vinci SP Surgical System (SP1098)
510(k) clearance, traditional: Substantially Equivalent
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Zimmer Biomet ZBHAction date Dec 2, 2025
Recall, Class II: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reacti…
Baxter International BAXAction date Nov 28, 2025
Recall, Class II: SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Filed as Baxter Healthcare Corporation · Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication o…
Danaher Corporation DHRAction date Nov 26, 2025
Recall, Class II: Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Filed as Beckman Coulter, Inc. · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the…
Danaher Corporation DHRAction date Nov 26, 2025
Recall, Class II: Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Filed as Beckman Coulter, Inc. · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the…
GE HealthCare GEHCAction date Nov 24, 2025
Device clearance (510(k)): Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Filed as GE Medical Systems Ultrasound and Primary Care Diagnostics · 510(k) clearance, traditional: Substantially Equivalent
Bristol Myers Squibb BMYAction date Nov 24, 2025
Drug approval: Opdivo Qvantig
Filed as BRISTOL-MYERS SQUIBB · New use approved (efficacy supplement). Active ingredient: Nivolumab, Hyaluronidase-Nvhy
Zimmer Biomet ZBHAction date Nov 24, 2025
Recall, Class II: Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Filed as Zimmer Surgical Inc · The devices may have a misaligned thickness control bar.
Abbott Laboratories ABTAction date Nov 24, 2025
Recall, Class I: FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
Filed as Abbott Diabetes Care, Inc. · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Abbott Laboratories ABTAction date Nov 24, 2025
Recall, Class I: FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
Filed as Abbott Diabetes Care, Inc. · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
100 of 1,161 shown; every record is on its company’s page.
Common questions
How many FDA records were there in 2025?
OQRO holds 1,161 FDA records in 2025 from FDA (Drugs@FDA, 510(k), PMA, enforcement reports), across 50 listed companies.
Which company had the most FDA records in 2025?
GE HealthCare (GEHC) has the most, with 133, ahead of Becton Dickinson (112) and Boston Scientific (92).
Where does the data come from?
FDA (Drugs@FDA, 510(k), PMA, enforcement reports), read on a schedule and matched to listed companies by name. Each record is matched to a listed company by the sponsor, applicant or recalling firm name as filed. The action date is the approval or decision date; for a recall, the date the firm started it. Unmatched firms (private companies, foreign subsidiaries under another name) are not listed.
