Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 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 19 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2024 | Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each ... | The protective pouches were identified to have been improperly labeled with UDI that is associate... | Class II | Medical Action Industries, Inc. 306 |
| Jan 15, 2024 | IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Ster... | The kits contain saline flush syringes which were recalled by the supplier. | Class II | Medical Action Industries, Inc. 306 |
| Nov 4, 2022 | Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter i... | XXX | Class II | Medical Action Industries, Inc. 306 |
| Oct 12, 2022 | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, ... | Scissors contained debris. | Class II | Medical Action Industries, Inc. 306 |
| Oct 12, 2022 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... | Class II | Medical Action Industries, Inc. 306 |
| Sep 15, 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car... | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10... | Class II | Medical Action Industries, Inc. 306 |
| Sep 8, 2021 | Kit: Central Line Dres Change 20/Cs | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat,... | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, R... | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| May 11, 2021 | novaplus, General Purpose Kit, Cat. No. 56603 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual uni... | Class II | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Dec 2, 2019 | Medical convenience trays and kits, labeled as: Medical Action Industries,... | The kits contain a bottle of saline solution which may exceed the USP specified pH requirements o... | Class II | Medical Action Industries, Inc. 306 |
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.