Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 1, 2021 | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter ... | Outer coating of the catheter may deteriorate and result in the coating to crack and/or potential... | Class II | Epimed International, Inc. |
| Feb 21, 2020 | R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124;... | Incorrect expiration date on introduction cannula packaging. | Class II | Epimed International |
| Feb 21, 2020 | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496;... | Incorrect expiration date on introduction cannula packaging. | Class II | Epimed International |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... | Class II | Epimed International, Inc. |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... | Class II | Epimed International, Inc. |
| Dec 28, 2017 | NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Dec 28, 2017 | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Potential for stylet to protrude from the distal end of the catheter | Class II | Epimed International |
| Jul 24, 2017 | COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit C... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic H... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Jul 24, 2017 | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plas... | Potential for partially incomplete seal of product, impacting sterility. | Class II | Epimed International |
| Apr 22, 2016 | 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the ep... | There is a possibility that the needles may have the potential to skive a catheters outer coatin... | Class II | Epimed 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.