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 |
|---|---|---|---|---|
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | 8MM,PROGRASP FORCEPS,IS4000 REF 471093 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm,... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 19, 2024 | 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2024 | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STER... | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safe... | Class II | Karl Storz Endoscopy |
| Dec 18, 2024 | Monitoring Service Application (MSA). Software to process, analyze, display, ... | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and ... | Class I | Braemar Manufacturing, LLC |
| Dec 15, 2024 | Calibrate CCX Interbody System for spinal fusion procedures: Implants: ... | Complaints have been received regarding post-operative implant collapse. | Class II | Alphatec Spine, Inc. |
| Dec 13, 2024 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reag... | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or... | Class II | Hologic, Inc. |
| Dec 11, 2024 | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... | Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent... | Class II | MICROVENTION INC. |
| Dec 3, 2024 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the inc... | Class III | Qualigen Inc |
| Dec 2, 2024 | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Impl... | Knee implant may fracture due to a supplier-related issue with one component that has nonconformi... | Class II | Moximed, Inc. |
| Dec 2, 2024 | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthc... | Class II | Accriva Diagnostics, Inc. |
| Dec 2, 2024 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... | Sterility assurance; microcatheter inner packaging may contain incomplete seal. | Class II | MICROVENTION INC. |
| Nov 27, 2024 | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. | Hydration issue resulting in the product being less cohesive and moldable than intended due to an... | Class II | IsoTis OrthoBiologics, Inc. |
| Nov 27, 2024 | OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, Osteo... | Incorrect expiration date listed on the outer box, which does not align with the correct expirati... | Class II | IsoTis OrthoBiologics, Inc. |
| Nov 26, 2024 | 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712... | Due to an increase of complaints for bracket bond failures and skin irritation or blistering. | Class II | 3M Unitek Corporation |
| Nov 21, 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... | Class II | Abbott Medical |
| Nov 14, 2024 | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis CII Safe ES, REF: 1116-00 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 12, 2024 | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 ... | Some units in a single production lot were programmed incorrectly which will result in the VivAer... | Class II | Aerin Medical, Inc. |
| Nov 8, 2024 | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog ... | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the ... | Class II | Beckman Coulter Inc. |
| Nov 8, 2024 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. | Class II | Hologic, Inc. |
| Nov 6, 2024 | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular p... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... | Due to finished goods incorrectly packaged and labeled. | Class II | ICU Medical, Inc. |
| Nov 6, 2024 | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in c... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascu... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 6, 2024 | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovas... | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... | Class II | Abbott Vascular Inc |
| Nov 1, 2024 | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, U... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 ... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Nov 1, 2024 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD... | On October 18, 2024, BD has identified through customer complaints and an increase in field failu... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small ... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 29, 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small... | Due to manufacturing defects observed on Locking Caps that affect the ability for components to m... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Oct 28, 2024 | Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of ... | Bronchoscopic visualization system power supplies have defective semiconductor components that ma... | Class II | Noah Medical |
| Oct 25, 2024 | Galaxy System (GAL-001) | Bronchoscopic system uninterruptable power may have defective component, may cause power supply s... | Class II | Noah Medical |
| Oct 25, 2024 | Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... | Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... | Class II | Noah Medical |
| Oct 21, 2024 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... | Due to improper labeling of products. An intended use on the label has not been reviewed and appr... | Class II | Karl Storz Endoscopy |
| Oct 11, 2024 | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... | Due to holes detected in the inner barrier system that may compromise the sterility of the affect... | Class II | Karl Storz Endoscopy |
| Oct 1, 2024 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Oct 1, 2024 | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... | Due to heart transmitter not being able to upgrade to the current software version in the field a... | Class III | Abbott Medical |
| Sep 30, 2024 | Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straig... | Due to potential issues with design, manufacturing and documentation issues related to the valida... | Class II | NuVasive Specialized Orthopedics, Inc. |
| Sep 27, 2024 | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... | Class II | Accriva Diagnostics, Inc. |
| Sep 25, 2024 | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... | Class II | Biocare Medical, LLC |
| Sep 23, 2024 | KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),... | The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s... | Class II | Pro-Dex 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.