Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 21, 2019 | Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... | The potential compromise of the sterility of products from an undersealed chevron in the packagin... | Class II | Cook Inc. |
| Oct 10, 2019 | SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 472358... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item N... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 3285... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 3... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 010055... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, Inc. |
| Oct 10, 2019 | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 ... | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | Class II | Zimmer Biomet, 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.