Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Aug 31, 2023 | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... | Class II | Access Vascular, Inc |
| Mar 3, 2023 | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter e... | Class II | Access Vascular, Inc |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... | Label with the incorrect component listed on the inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... | Product Mislabeled on the outer bag and inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Feb 24, 2021 | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Periphe... | Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shor... | Class II | Access Vascular, 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.