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
Oct 24, 2023	Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A	The efficacy of the manual cleaning process cannot be assured for the affected injection needles ...	Class II	Karl Storz Endoscopy
Oct 18, 2023	Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w	Their is the potential that software issues may result in flipped image of the virtual Bronchosc...	Class II	AURIS HEALTH INC
Oct 18, 2023	Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w	Their is the potential that software issues may result in flipped image of the virtual Bronchosc...	Class II	AURIS HEALTH INC
Oct 18, 2023	Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w	Their is the potential that software issues may result in flipped image of the virtual Bronchosc...	Class II	AURIS HEALTH INC
Oct 6, 2023	Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm	There is the potential for the needle drive to become dislodged and/or broken which could result ...	Class II	Intuitive Surgical, Inc.
Oct 5, 2023	MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00;...	If "Clear All" selected medications is selected on patient profile, the automated dispensing cabi...	Class II	CareFusion 303, Inc.
Oct 4, 2023	Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Oct 4, 2023	Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on...	Their is the potential for flushing difficulties during setup of the pressure monitoring kit with...	Class II	Edwards Lifesciences, LLC
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocu...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraoc...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocu...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocul...	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 29, 2023	EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	Class II	Staar Surgical Company
Sep 23, 2023	SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Refe...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 23, 2023	CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref ...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 23, 2023	SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) n...	Due to potential air pockets between layers of material, their is the potential for complete stru...	Class II	Townsend Design
Sep 21, 2023	TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with ...	When using affected curette and software, there is a discrepancy between the actual curette tip l...	Class II	Acclarent, Inc.
Sep 15, 2023	BD Alaris PCU REF 8015	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
Sep 15, 2023	BD Alaris Syringe Module, REF 8110	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
Sep 15, 2023	Alaris PCA Module 8120	Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ...	Class I	CareFusion 303, Inc.
Sep 14, 2023	Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW...	Use of assay along with plasma specimen may result in error code which would invalidate sample.	Class II	Hologic, Inc.
Sep 13, 2023	BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walkin...	Due to walkers not meeting product specifications. Walkers were manufactured with misaligned whe...	Class II	Breg Inc
Sep 13, 2023	Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposa...	Expired product distributed	Class II	Stryker Corporation
Sep 7, 2023	Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35	Inadvertent release of embolectomy catheters that may experience slower than normal balloon defla...	Class II	Edwards Lifesciences, LLC
Sep 6, 2023	BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wi...	When global edit is used to update multiple formulary properties simultaneously, the following pr...	Class II	CareFusion 303, Inc.
Aug 31, 2023	Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP	Endobronchial implant devices may have been labeled with a shortened expiration date but they can...	Class II	Pulmonx, Corp.
Aug 24, 2023	AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324	Peripheral coil system detachable has a potential of unsealed pouch packaging.	Class II	MICROVENTION INC.
Aug 23, 2023	Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462	Expired Product distributed	Class II	Stryker Corporation
Aug 18, 2023	Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC866...	The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the pro...	Class II	North Coast Medical Inc
Aug 18, 2023	Constellation Vision System, REF: 8065751150	Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could ...	Class II	Alcon Research, LLC
Aug 18, 2023	BD Pyxis MedBank MedPass Software, REF: 139088-01	After dispensing a timed dose medication for a patient, the automated dispensing cabinet software...	Class II	CareFusion 303, Inc.
Aug 16, 2023	Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH...	Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card...	Class II	Abbott Medical
Aug 16, 2023	Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal...	Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card...	Class II	Abbott Medical
Aug 7, 2023	Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart...	Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical...	Class II	Thoratec Corp.
Jul 27, 2023	PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS	Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mi...	Class II	Edwards Lifesciences, LLC
Jul 18, 2023	Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, S...	The healing abutments contain a dimensional condition that may lead to a gap between the healing ...	Class II	Preat Corp
Jul 18, 2023	Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Ste...	The healing abutments contain a dimensional condition that may lead to a gap between the healing ...	Class II	Preat Corp
Jul 18, 2023	Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, S...	The healing abutments contain a dimensional condition that may lead to a gap between the healing ...	Class II	Preat Corp
Jul 14, 2023	COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 100...	Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected t...	Class II	Copan Diagnostics Inc
Jul 12, 2023	Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2	Lipemic interference failed to meet the performance specification listed within the IFU.	Class II	Beckman Coulter 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.