Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Dec 9, 2021 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or E... Potential deformation of the internal packaging (blister pack) could compromise sterile barrier o... Class II DIXI MEDICAL USA
Dec 3, 2021 Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Dec 3, 2021 Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7m... Incorrect product is contained in the packaging. Class II Wright Medical Technology, Inc.
Dec 3, 2021 Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. The incorrect product is contained in the packaging. Class II Wright Medical Technology Inc
Dec 1, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... Class II CELLTRION USA INC
Nov 17, 2021 Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in c... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid i... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 17, 2021 Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in... Kit packaging may have small holes compromising product sterility Class II Beaver Visitec International, Inc.
Nov 4, 2021 regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn... The kit contains a non-sterile needle. Class II ROi CPS LLC
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-li... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long ... Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Nov 2, 2021 RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 Potential for open packaging seals compromising the sterility of the surgical gowns Class II Cardinal Health
Sep 27, 2021 BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used... Holes in product packaging impacts package integrity and may compromise sterility. Class II Becton Dickinson & Company
Sep 22, 2021 QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleedin... Lack of Packaging seal integrity may result in a sterile barrier breach. Class II Z-Medica, LLC
Sep 9, 2021 ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacem... Packaging may include screws that are not intended to be used with the 5mm augments, may cause de... Class II DePuy Orthopaedics, Inc.
Sep 8, 2021 BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Cathe... There is a breach in the product packaging that renders the product non-sterile. Class II Becton Dickinson Infusion Therapy Systems Inc.
Aug 20, 2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Primary packaging labeling may be incorrect. Class II ConvaTec, Inc
Aug 19, 2021 Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 888157012... Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits.... Class I Windstone Medical Packaging, Inc.
Aug 6, 2021 TECNIS Eyhance IOLs are permanent intraocular implants intended for implantat... Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels h... Class II Johnson & Johnson Surgical Vision Inc
Aug 5, 2021 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stab... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLoc... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" St... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard 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.