Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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Date	Product	Reason	Class	Firm
Dec 19, 2024	8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172	Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j...	Class II	Intuitive Surgical, Inc.
Dec 19, 2024	8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093	Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j...	Class II	Intuitive Surgical, Inc.
Dec 19, 2024	8MM,CADIERE FORCEPS,IS4000 REF 471049	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 NEEDLE DRIVER,IS4000¿ REF 470194	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: 27030KB, Pediatric Cysto-Urethroscope, NON STERI...	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,RESANO FORCEPS,IS4000 ¿ REF 470181	Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j...	Class II	Intuitive Surgical, Inc.
Dec 19, 2024	8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033	Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j...	Class II	Intuitive Surgical, Inc.
Dec 19, 2024	8MM,LONG TIP FORCEPS,IS4000 REF 471048	Due to increased complaints regarding frayed or broken grip cables on reusable instruments with j...	Class II	Intuitive Surgical, Inc.
Dec 19, 2024	8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205	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: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON ST...	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,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246	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: 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

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.