Browse Device Recalls

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Nov 15, 2017 Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im... Class II Implant Direct Sybron Manufacturing, LLC
Nov 14, 2017 Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591... The recalled lots have demonstrated unexpected false positive THC results. Class II Alere San Diego, Inc.
Nov 10, 2017 iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca... iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc... Class II Beckman Coulter Inc.
Nov 6, 2017 Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit... Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... Class III Beckman Coulter Inc.
Nov 6, 2017 UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro... Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... Class III Beckman Coulter Inc.
Nov 6, 2017 Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used... Reports of incorrect priming volume due to manufacturing with incorrect tubing. Class II CareFusion 303, Inc.
Nov 6, 2017 Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de... Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... Class III Beckman Coulter Inc.
Nov 3, 2017 UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hema... The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... Class II Beckman Coulter Inc.
Nov 3, 2017 Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) R... On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during us... Class II Volcano Corporation
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Nov 3, 2017 UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: ... The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... Class II Beckman Coulter Inc.
Nov 3, 2017 Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Nov 3, 2017 UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... Class II Beckman Coulter Inc.
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... Class II Stryker Neurovascular
Oct 29, 2017 OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use... It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the f... Class III Xintec Corp
Oct 24, 2017 ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of... Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is ... Class II Radiometer America Inc
Oct 18, 2017 Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (... Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled... Class II Bioseal Corporation
Oct 11, 2017 Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 11, 2017 Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu... The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... Class II Zimmer Dental Inc
Oct 10, 2017 Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink... Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so... Class II Medtronic Inc.
Oct 10, 2017 ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implan... One reported complaint and discovered that the outer vial was out of round and undersized. There... Class II Implant Direct Sybron Manufacturing, LLC
Oct 10, 2017 STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out... The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo... Class II Karl Storz Endoscopy
Oct 9, 2017 Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 10... Cepheid has received reports that some of our customers have experienced a higher number of temp... Class II Cepheid
Oct 2, 2017 AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... The system may duplicate sample requests leading to sample misidentification when connected to a ... Class II Beckman Coulter Inc.
Oct 2, 2017 Hemosphere System with the following three components: HEM1 Advanced Monitor,... Pre-procedural issues related to software defects Class II Edwards Lifesciences, LLC
Sep 30, 2017 Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... Product was released to market without the adulteration strip included in the product. Class III Ameditech Inc
Sep 19, 2017 daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitiv... Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in ... Class II Intuitive Surgical, Inc.
Sep 15, 2017 Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reve... Customers have reported a higher than expected number of invalid test results when using the reca... Class II Cepheid
Sep 15, 2017 Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In... An incorrect incubator was installed on one Panther System which potentially led to incorrect Apt... Class II Hologic, Inc
Sep 13, 2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... It was determined that the deflection length indicated on the Guide catheter handle does not matc... Class II Medtronic Vascular, Inc.
Sep 12, 2017 Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is ... During an examination images were displayed on the live monitor,but the images were not displayed... Class II Toshiba American Medical Systems Inc
Sep 10, 2017 Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 7, 2017 AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood ga... Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give i... Class II Radiometer America Inc
Sep 6, 2017 THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-13270... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S) Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Sep 6, 2017 THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S,... Biosense Webster, Inc. has recently received an increased number of complaints related to the dis... Class II Biosense Webster, Inc.
Sep 1, 2017 AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500... The recommended storage temperature on the label is incorrect. Class II Aaren Scientific Inc.
Aug 31, 2017 SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 ... ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metal... Class II ICU Medical, Inc.
Aug 28, 2017 Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: ... The device may exhibit premature battery depletion. Class I St Jude Medical Inc.
Aug 28, 2017 PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) dev... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker ... New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our p... Class II St Jude Medical Inc.
Aug 28, 2017 Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Nu... The device may exhibit premature battery depletion. Class I St Jude Medical 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.