Browse Device Recalls
20 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 20 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 20 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 8, 2014 | Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for rei... | The patient record peel-off label product code and size did not match the other labeling and actu... | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 ... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indica... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 ... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 In... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Ind... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 I... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 In... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for us... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 I... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in t... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indi... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 ... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 I... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Apr 24, 2014 | Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use... | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Jan 3, 2014 | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P ... | Product labeling does not match product configuration. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Jan 3, 2014 | Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Me... | Product labeling does not match product configuration. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Sep 4, 2012 | Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Cod... | Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" pac... | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Sep 4, 2012 | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Co... | Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" pa... | Class II | Davol, Inc., Subs. 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.