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
Sep 8, 2026 Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Cata... Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploite... Class II Nihon Kohden America LLC
Sep 2, 2026 DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 ... Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when test... Class II Beckman Coulter Inc.
Sep 2, 2026 DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, ... Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testin... Class II Beckman Coulter Inc.
Aug 26, 2026 Alphenix INFX-8000C/B5 Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shi... Class II Canon Medical System, USA, INC.
Aug 21, 2026 iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x6... The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity t... Class II SI-BONE, Inc.
Aug 20, 2026 Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalo... Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or ab... Class II Medtronic MiniMed, Inc.
Aug 20, 2026 Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; M... hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... Class II Alere San Diego, Inc.
Aug 20, 2026 McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG C... hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... Class II Alere San Diego, Inc.
Aug 20, 2026 Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry S... hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... Class II Alere San Diego, Inc.
Aug 20, 2026 Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FH... hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... Class II Alere San Diego, Inc.
Aug 19, 2026 SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached ... The proximal thread depth of the spinal device is out of design specification. Class II SEASPINE ORTHOPEDICS CORPORATION
Aug 17, 2026 MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, R... Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, L... Class II Microgenics Corporation
Aug 12, 2026 HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL S... Due to incorrect inside packaging label for eyepiece. Class II Karl Storz Endoscopy
Aug 11, 2026 ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 006901032109... Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetr... Class II Becton, Dickinson and Company
Aug 7, 2026 Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501... Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and ef... Class II Happiest Baby, Inc
Aug 7, 2026 Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101... Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and ef... Class II Happiest Baby, Inc
Aug 6, 2026 Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1... Software system may associate image data from one patient with another patient's record, potenti... Class II Volcano Corp
Aug 4, 2026 Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digit... Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X... Class II Canon Medical System, USA, INC.
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 31, 2026 JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... Class II Jenavalve Technology Inc.
Jul 31, 2026 HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 103000... Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical catarac... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 24, 2026 Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penu... Due to manufacturing issues reperfusion catheters may fracture. Class II Penumbra Inc.
Jul 16, 2026 Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Appl... A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software i... Class II Tandem Diabetes Care, Inc.
Jul 15, 2026 Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5... a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... Class II Beckman Coulter Inc.
Jul 15, 2026 Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1... a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... Class II Beckman Coulter Inc.
Jul 13, 2026 MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 13, 2026 MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 13, 2026 MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 2, 2026 OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17... Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone gra... Class II IsoTis OrthoBiologics, Inc.
Jun 26, 2026 REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic install... Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... Class II Beckman Coulter Inc.
Jun 26, 2026 REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the foll... Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... Class II Beckman Coulter Inc.
Jun 25, 2026 Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI... Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but un... Class II Micro Therapeutics, Inc.
Jun 23, 2026 Charger for the Therabody Theragun, G4 PRO massage device, and products which... Charging cradle for the device may overheat while charging the device's removable battery pack, p... Class II Therabody, Inc
Jun 17, 2026 INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... Class I Boston Scientific Neuromodulation Corporation
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 16, 2026 MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and misse... Class II Medtronic MiniMed, Inc.
Jun 8, 2026 STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefideroc... Due to incorrect cartridges include in affected products that there is the potential for false-su... Class II Hardy Diagnostics
Jun 8, 2026 STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 3, 2026 Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT Due to manufacturing issues, reperfusion catheters may fractures Class II Penumbra, Inc.
May 28, 2026 SeaSpine Polyaxial Head REF Number: 41-3010 Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following... Class II SEASPINE ORTHOPEDICS CORPORATION
May 27, 2026 MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... Class II Medtronic MiniMed, Inc.
May 27, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction wer... Class II Dexcom, 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.