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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Dec 19, 2017 PerkinElmer 226 Sample Collection Device PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p... Class III PerkinElmer Health Sciences, Inc.
May 31, 2017 PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 21, 2016 Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... AutoDELFIA System with Version 3.0 Software: Potential plate loading failures Class III PerkinElmer Health Sciences, Inc.
Dec 5, 2016 EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... Unique Device Identifier (UDI) is missing from outer kit box label. Class III PerkinElmer Health Sciences, Inc.
Dec 1, 2016 Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... Class II PerkinElmer Health Sciences, Inc.
Nov 16, 2016 DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat... Class III PerkinElmer Health Sciences, Inc.
Jul 1, 2014 Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument ... Risk of incorrect results from samples prepared with Panthera-Puncher 9 Class II PerkinElmer Health Sciences, Inc.
Jun 27, 2014 PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... Potential for demographic information and test result to be mismatch. Class II PerkinElmer Health Sciences, 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.