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 |
|---|---|---|---|---|
| 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. |
| Jul 12, 2023 | FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li... | If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'... | Class II | Abbott Diabetes Care, Inc. |
| Jul 7, 2023 | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine... | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventin... | Class II | Alphatec Spine, Inc. |
| Jul 7, 2023 | Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only | Flexible intubation endoscopes sterility assurance can not be confirmed. | Class II | Karl Storz Endoscopy |
| Jul 6, 2023 | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Jul 6, 2023 | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Jun 28, 2023 | Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... | Product labeling contains incorrect expiration date | Class II | Medtronic Neurosurgery |
| Jun 22, 2023 | INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C... | The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t... | Class II | Canon Medical System, USA, INC. |
| Jun 14, 2023 | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... | There is a potential for the direct amplification disc to malfunction which may result in spilla... | Class II | DiaSorin Molecular LLC |
| Jun 13, 2023 | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ... | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-pro... | Class II | Medtronic Neurosurgery |
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.