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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Jul 14, 2023 Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrog... For administration of intravenous fluids to a patient s vascular system utilizing needle-free com... Class II Quest Medical, Inc.
Dec 23, 2022 Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set wi... Delivery Sets may have tubing that could become detached that could result in patient infection. Class II Quest Medical, Inc.
Dec 17, 2019 Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168... Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ... Class II Quest Medical, Inc.
Oct 28, 2015 Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat e... The products have been found to intermittently exhibit a seal failure during use. Class II Quest Medical, Inc.
Feb 26, 2015 LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthal... Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels Class II Quest Medical, 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.