Browse Device Recalls

774 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 774 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 774 FDA device recalls.

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DateProductReasonClassFirm
May 22, 2018 Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat.... The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... Class II Randox Laboratories Ltd.
May 22, 2018 Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat.... The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... Class II Randox Laboratories Ltd.
May 8, 2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... Class II Luminex Corporation
Apr 30, 2018 PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 25, 2018 Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... Class II Conseal International, Inc.
Apr 20, 2018 Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... Complaints where users were unable to prime the administration set. Class II CareFusion 303, Inc.
Apr 19, 2018 MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be ... Class II MicroAire Surgical Instruments, LLC
Apr 2, 2018 PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The P... The connector of the power supply was capable of fitting other components provided with the syste... Class II Bio-Rad Laboratories Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 26, 2018 AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. Class II Tornier, Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 23, 2018 Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 23, 2018 The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... Class II BioMerieux SA
Mar 16, 2018 Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... Potential risk for helium gas inside the MR examination room during a magnet quench Class II Philips Electronics North America Corporation
Mar 15, 2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... Class II Biocare Medical, LLC
Mar 12, 2018 Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TM... This device was mislabeled and is not the correct component for this patient. Class II TMJ Solutions Inc
Mar 12, 2018 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 c... Products have been packaged with the wrong Trocar length type. Class II CooperSurgical, Inc.
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... Class II Roche Diagnostics Corporation
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM ST... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 13... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 D... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL ... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nai... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 20, 2017 ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 D... Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system af... Class II Zimmer Biomet, Inc.
Dec 15, 2017 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... Class II DePuy Spine, Inc.
Oct 16, 2017 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... Class II Stryker Instruments Div. of Stryker Corporation
Sep 27, 2017 Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR... There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirm... Class II WalkMed, LLC
Aug 1, 2017 Presource(R) Kits (custom surgical/procedural kits): The standard and custom... The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... Class II Cardinal Health 200, LLC
Jul 27, 2017 Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... A leak may allow for microbial contamination of the sterile fluid path. Class II Baxter Healthcare Corporation
Jul 27, 2017 iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class II Optovue, Inc.
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 15, 2017 Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... Class II Custom Assemblies Inc
Jun 6, 2017 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Apr 17, 2017 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... nail not properly engaging with the targeting jig due to certain undersized specification Class II Zimmer Biomet, Inc.
Apr 6, 2017 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... Class II Amendia, Inc
Mar 31, 2017 Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM There is a risk that the pinion gear in the device could fail under extreme use cases. Class II Ethicon Endo-Surgery Inc
Mar 20, 2017 Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The A... Arrow International initiated the recall due to reports of safety cover disengagement and needles... Class II Arrow International Inc
Mar 7, 2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... Class II Aesculap Implant Systems LLC
Feb 23, 2017 Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... Class II Philips Medical Systems (Cleveland) Inc
Feb 23, 2017 Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... Class II Philips Medical Systems (Cleveland) Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.