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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 4, 2017 MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of... There is a potential for the slope of the standard curve to fail to meet the assay validation req... Class II Diagnostic Hybrids, Inc.
Oct 26, 2016 Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the qu... There may be a loss of separation between Calibrators A and B which may impact the assay calibrat... Class III Diagnostic Hybrids, Inc.
Jul 14, 2016 MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specifi... There is a possibility of low volume and/or leaking standard bottles. Class II Diagnostic Hybrids, Inc.
Nov 3, 2015 MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection o... A component of the kit was found to contain bacterial contamination. Class III Diagnostic Hybrids, Inc.
Nov 3, 2015 MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. ... A component of the kit was found to contain bacterial contamination. Class III Diagnostic Hybrids, Inc.
Nov 3, 2015 MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the... A component of the kit was found to contain bacterial contamination. Class III Diagnostic Hybrids, Inc.
Dec 31, 2012 Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T... RhMK product fungal contamination. Class III Diagnostic Hybrids 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.