Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 5, 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... | Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... | Class II | GE Healthcare, LLC |
| Nov 19, 2013 | NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green... | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... | Class II | Zimmer, Inc. |
| Nov 19, 2013 | NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm He... | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... | Class II | Zimmer, Inc. |
| Nov 19, 2013 | NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm He... | This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... | Class II | Zimmer, Inc. |
| Nov 13, 2013 | Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... | Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... | Class II | Integra LifeSciences Corp. |
| Nov 13, 2013 | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... | KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... | Class II | Karl Storz Endoscopy America Inc |
| Nov 13, 2013 | Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... | Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... | Class II | Integra LifeSciences Corp. |
| Nov 8, 2013 | Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems fo... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usag... | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage... | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Nov 8, 2013 | UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, a... | Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... | Class II | Beckman Coulter Inc. |
| Oct 31, 2013 | NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Ti... | Two complaints were received in which it was reported that the stem would not lock into the tibia... | Class II | Zimmer, Inc. |
| Oct 25, 2013 | REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... | Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... | Class II | Biomet, Inc. |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 23, 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf... | The affected lots were exposed to a higher than acceptable level of particulate matter during man... | Class II | ConMed Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-rei... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. ... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 23, 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 21, 2013 | ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... | Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. | Class I | Medtronic Vascular |
| Oct 13, 2013 | Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needl... | Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... | Class II | Restoration Robotics |
| Oct 13, 2013 | ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inn... | Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... | Class II | Restoration Robotics |
| Oct 13, 2013 | ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Va... | Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... | Class II | Restoration Robotics |
| Oct 13, 2013 | Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if ster... | Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... | Class II | Restoration Robotics |
| Oct 10, 2013 | Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... | Investigation identified that the design of the drill bit may make the suture anchor difficult to... | Class II | Biomet, Inc. |
| Oct 10, 2013 | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... | Nanosphere has received several reports relating to an increased rate of Processing Errors during... | Class II | Nanosphere, Inc. |
| Sep 30, 2013 | Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I... | Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c... | Class I | Merit Medical Systems, Inc. |
| Sep 30, 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... | Class II | Medtronic Neuromodulation |
| Sep 30, 2013 | Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P ... | A potential non conformance was identified with the Zero-P VA plate where the screw could back ou... | Class II | Synthes USA HQ, Inc. |
| Sep 24, 2013 | COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyz... | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and C... | Class II | Beckman Coulter Inc. |
| Sep 23, 2013 | Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthe... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Ane... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Ane... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 Th... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesth... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-2... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthe... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional An... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesth... | Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... | Class II | Smiths Medical ASD, Inc. |
| Sep 23, 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... | The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... | Class I | Baylis Medical Corp * |
| Sep 10, 2013 | Dual Luer Lock Cap The device is intended for use as a cap for male or fem... | The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... | Class II | Baxter Healthcare Corp. |
| Aug 30, 2013 | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. ... | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (L... | Class II | Implantech Associates Inc |
| Aug 29, 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Cla... | An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not eas... | Class II | Integra LifeSciences Corp. |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew 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.