Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2015 | Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:D... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Nu... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog N... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numb... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUB... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, si... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog ... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Apr 16, 2015 | ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Nu... | Devon Light Gloves contain splits or holes compromising the sterility | Class II | Covidien LLC |
| Mar 26, 2015 | 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Troc... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main c... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 23, 2015 | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Feb 26, 2015 | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telesco... | Leaks were detected in the recalled lot which may compromise the sterility of the product. | Class II | Civco Medical Instruments Inc |
| Feb 16, 2015 | Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000)... | There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have... | Class II | Intuitive Surgical, Inc. |
| Feb 13, 2015 | - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio ... | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of t... | Class II | Medela Inc. EF Division |
| Feb 5, 2015 | Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, ... | The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... | Class II | Zipline Medical |
| Feb 5, 2015 | Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product numbe... | The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... | Class II | Zipline Medical |
| Feb 5, 2015 | Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product numb... | The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... | Class II | Zipline Medical |
| Jan 9, 2015 | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965P... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog N... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No.... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 600... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 6... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 602... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 601... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Jan 9, 2015 | NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, ... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, 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.