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 |
|---|---|---|---|---|
| Nov 20, 2019 | Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... | Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... | Class II | Datascope Corporation |
| Nov 13, 2019 | Lamicel 20PK 3MM INTL Cervical dilator | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Nov 13, 2019 | Lamicel 20PK 5MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Nov 13, 2019 | Lamicel 10PK 10MM INTL | Routine sterilization dose does not meet the required Sterility Assurance Level. | Class II | Medtronic Xomed, Inc. |
| Nov 7, 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in... | Class II | Ethicon Endo-Surgery Inc |
| Oct 24, 2019 | Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT... | Sterile packaging incomplete seals may compromise sterility of the product | Class II | Centurion Medical Products Corporation |
| 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 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. |
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.