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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Feb 2, 2018 PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 leve... To correct the kit's instructions for use as the storage time for gastric and gastroesophageal ju... Class II Dako North America Inc.
Jun 10, 2016 Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi... Class II Dako North America Inc.
Sep 4, 2015 EnVision FLEX/HRP visualization reagent found in the following kits: EnVisio... There is a defect in one lot of a buffer, non-specific background staining that has, in some inst... Class II Dako North America Inc.
Apr 1, 2015 Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... Class II Dako North America Inc.
Feb 12, 2015 Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autost... A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopc... Class II Dako North America Inc.
Aug 29, 2014 Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS4... Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has d... Class II Dako North America Inc.
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
May 1, 2008 PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an auto... Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, ... Class II Dako North America 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.