Browse Device Recalls

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Jun 20, 2016 Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ... Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h... Class II Karl Storz Endoscopy
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.
Jun 8, 2016 Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramag... Demonstrate an upward shift in patient results. Class II Beckman Coulter Inc.
Jun 7, 2016 Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o... Instructions For Use had incorrect lot number and calibrator values Class III Tosoh Bioscience, Inc.
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M003542... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
May 24, 2016 TriFoillmaging Triumph/Triumph II Research CT scanners. The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northrid... Class II Northridge Tri-Modality Imaging,
May 24, 2016 QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systemat... Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improp... Class II Hardy Diagnostics
May 20, 2016 Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP becau... Class II SSC- Surgical Specialties Corporation
May 19, 2016 Toshiba Ultimax DREX-ULT80 X-ray generator It was discovered that the generator of the system could possibly terminate the exposure prematur... Class II Toshiba American Medical Systems Inc
May 19, 2016 Toshiba Kalare DREX-KL80 X-ray generator It was discovered that the generator of the system could possibly terminate the exposure prematur... Class II Toshiba American Medical Systems Inc
May 19, 2016 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08... The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged ... Class II Implant Direct Sybron Manufacturing, LLC
May 17, 2016 AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuo... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventila... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ven... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanic... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuo... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilat... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mech... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator in... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion
May 17, 2016 Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro... Due to the lack of updated thermal components, these instruments may be more susceptible to the i... Class II Beckman Coulter Inc.
May 17, 2016 AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) ... CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect... Class I Carefusion 211 Inc dba Carefusion

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.