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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.