Browse Device Recalls
3,133 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,133 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 3,133 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 5, 2021 | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine ... | There is potential for packaging defects that may impact the sterile barrier. | Class II | C.R. Bard Inc |
| Aug 3, 2021 | Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number:... | Packaging seal defect may allow a breach of the package sterile barrier and result in patient inf... | Class II | Olympus Corporation of the Americas |
| Jul 29, 2021 | ECHELON Oval MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 28, 2021 | Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
| Jul 28, 2021 | Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 3... | The packaging system on the devices have potential physical and water damage resulting in damage ... | Class II | Corin Ltd |
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.