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
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.
Jan 29, 2018 AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytomet... The device may process the same sample with two different sample IDs and sample information while... Class II Beckman Coulter Inc.
Jan 26, 2018 QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, h... The device power supply was not manufactured according to specification which can result in the l... Class II Inova Diagnostics Incorporated
Jan 26, 2018 QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, h... The device power supply was not manufactured according to specification which can result in the l... Class II Inova Diagnostics Incorporated
Jan 26, 2018 ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imag... The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to ... Class II Siemens Medical Solutions USA, Inc.
Jan 25, 2018 CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... The recalled products were shipped without the required temperature control packaging, therefore ... Class II Stryker Corporation
Jan 23, 2018 Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... Class II Implant Direct Sybron Manufacturing, LLC
Jan 20, 2018 Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: Th... The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and... Class II Hologic, Inc
Jan 19, 2018 AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125... Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing pr... Class II Beckman Coulter Inc.
Jan 19, 2018 SwishTapered Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... Class II Implant Direct Sybron Manufacturing, LLC
Jan 19, 2018 SwishPlus Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... Class II Implant Direct Sybron Manufacturing, LLC
Jan 18, 2018 AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standar... A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to caus... Class II Beckman Coulter Inc.
Jan 12, 2018 COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Jan 12, 2018 Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiograp... When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or ch... Class II Shimadzu Medical Systems
Jan 12, 2018 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Jan 11, 2018 Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO... Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color ba... Class II TriMed Inc.
Jan 11, 2018 ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, ... Sterility failure found in one of the units in the lot. Class II Ellex iScience, Inc.
Jan 5, 2018 Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... Class II ICU Medical, Inc.
Jan 4, 2018 Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 ... The power supply unit may be damaged and may fail to start up when the power plug is inserted int... Class II Toshiba American Medical Systems Inc
Dec 29, 2017 INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM During an examination a device error occurred and the ceiling drive operation was disabled. It wa... Class II Toshiba American Medical Systems Inc
Dec 29, 2017 INFX-8000H Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. It wa... Class II Toshiba American Medical Systems Inc
Dec 29, 2017 INFX-8000F Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. It wa... Class II Toshiba American Medical Systems Inc
Dec 29, 2017 INFX-8000C Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. It wa... Class II Toshiba American Medical Systems Inc
Dec 27, 2017 Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers ... Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). Class II Ormco/Sybronendo
Dec 21, 2017 Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetri... The kits contained an incorrect lot of Dropper Plus Level 1 vials Class III Quantimetrix Corporation
Dec 21, 2017 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per bo... Inadvertent shipment of expired units. Class II Stryker Corporation
Dec 20, 2017 Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... Medtronic is initiating a voluntary recall because the products identified above did not adequate... Class II Medtronic Neurosurgery
Dec 20, 2017 AUTO REF/KERATOMETER ARK-1s There is possibly a difference between the measured dioptric value of the subjective measurement ... Class II Nidek Inc.
Dec 15, 2017 Alere iScreen Dx Urine Drug Screen Card The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti... Class III Ameditech Inc
Dec 15, 2017 Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in... The calibration for the affected batch of analyzers was incorrectly set during the manufacturing ... Class II Quidel Corporation
Dec 14, 2017 Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded... Torn sheath liner material was detected at the proximal end of the device during internal product... Class II Kalila Medical
Dec 14, 2017 Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is w... Torn sheath liner material was detected at the proximal end of the device during internal product... Class II Kalila Medical
Dec 6, 2017 Health Harmony Mobile application software Product Usage: Care Innovatio... It was discovered that in certain situations, including partial sessions and when taking adhoc me... Class II Intel-GE Care Innovations LLC
Dec 4, 2017 iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... Class II Beckman Coulter Inc.
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 29, 2017 Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... Class II Hologic, Inc.
Nov 29, 2017 Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... Class II Zimmer Dental Inc
Nov 29, 2017 Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... Class II Hologic, Inc.
Nov 28, 2017 lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/... The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce value... Class III Alere San Diego Inc. DBA Immunalysis Corporation
Nov 28, 2017 Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm an... Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactu... Class II Stryker Neurovascular
Nov 21, 2017 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2017 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 20, 2017 Tapered Screw-Vent MTX Model TSVTB11 Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a man... Class II Zimmer Dental Inc
Nov 17, 2017 EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry tr... Firm became aware that it distributed 7 units in the U.S. that included a function that had not b... Class II Edan Diagnostics
Nov 17, 2017 StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II CareFusion 303, Inc.
Nov 17, 2017 ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation
Nov 17, 2017 Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th... The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... Class II CareFusion 303, Inc.
Nov 17, 2017 STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod... Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... Class II Stryker Corporation

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.