Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 8, 2014 | Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Uretheral Catheter Tray, Catalog number 900-278. 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 | Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform p... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Open Heart Tray, Catalog number 900-1196C Used by medical staff to perfor... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perfor... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Total Hysterectomy, catalog #900-2415 Used by medical staff to perform pat... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform pa... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Fanfold Drape, Catalog number 900-633. Used by medical staff to perform pa... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe... | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform ... | Customed products are being recalled because of compromised sterility, not limited to potentially... | Class I | Customed, Inc |
| Oct 8, 2014 | Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform... | 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.