Browse Device Recalls
13 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 13 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 13 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 26, 2018 | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. ... | Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a nee... | Class II | Beaver-Visitec International Inc. |
| Feb 26, 2018 | Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Numbe... | Products were packaged with incorrect labeling, | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Produc... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| Nov 3, 2017 | bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 ... | The protective shield was retracted, and the blade was exposed. | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 1, 2015 | BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Gl... | Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product | Class II | Beaver-Visitec International Inc. |
| May 6, 2014 | Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannula... | Contains a sharp tip needle when the product should contain a blunt tip cannula | Class II | Beaver-Visitec International 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.