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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
May 19, 2015 Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each... A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in ... Class II Pointe Scientific, Inc.
Mar 13, 2015 Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ... Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ... Class III Pointe Scientific, Inc.
Dec 12, 2014 Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... Class III Pointe Scientific, 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.