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 |
|---|---|---|---|---|
| Jan 9, 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, 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, 3V MANIFOLD KIT, UPN H965601011621, 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, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996... | 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 H749600329421, REF/Catalog No. 60032942, 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 H749601605351, 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 KIT, UPN H749600618011, 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 H749601506721, 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 H7496005216131, REF/Catalog No. 600521613, 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/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog ... | 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, PTCA KIT, UPN H9656019110161, REF/Catalog No. 60191101... | 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, UPN H7496006044121, REF/Catalog No. 600604... | 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 H965601955411, REF/Catalog No. 60195541, 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 H749606204751, REF/Catalog No. 60620475, 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 H749601617931, 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 H965607011741, REF/Catalog No. 60701174, 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 H749601827221, REF/Catalog No. 60182722, 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 H749602322341, 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, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalo... | 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 H749600203741, REF/Catalog No. 60020374, 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 H7496016046121, REF/Catalog No. 601604612, 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, 5 VALVE MANIFOLD KIT, UPN H749600105121, 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, MOBILE CATH LAB KIT, UPN H749600419211, 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 H7496007057101, 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 H7496013148131, REF/Catalog No. 601314813, 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 H749602001451, REF/Catalog No. 60200145, 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 H749601308341, REF/Catalog No. 60130834, 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, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185... | 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 KIT CARDIOVASCULAR PROCEDURE KIT, UPN H7496004... | 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 H749602301481, REF/Catalog No. 60230148, 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 H749602207461, 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, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 6006... | 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 H749600407061, 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, UPN H965601931651, REF/Catalog No. 60193165, 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 H749601904231, REF/Catalog No. 60190423, 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, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 6015... | 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, RADIOLOGY KIT, UPN H7496002072111, 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, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 600709... | The labelled expiration dating of the affected product is not fully supported by shelf life verif... | Class II | Navilyst Medical, Inc |
| Nov 21, 2014 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... | Affected product may have compromised sterility due to packaging defects. It was determined that ... | Class II | Atricure Inc |
| Oct 17, 2014 | Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethic... | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expec... | Class II | Ethicon, Inc. |
| Oct 8, 2014 | Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Extremity PACK, catalog #900-2615 Used by medical staff to perform patient... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, 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.