Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 15, 2023 | The INFX-8000F is designed to take advantage of the latest technological inno... | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal image... | Class II | Canon Medical System, USA, INC. |
| Nov 2, 2023 | Sperm separation media are used to separate motile sperm from other constitue... | The lower layer component of a sperm separation Kit does not match the certificate of analysis. T... | Class II | Fujifilm Irvine Scientific, Inc. |
| Oct 25, 2023 | CD11b APC: ASR, REF: 340936, and CE, REF: 333143 | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluor... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 24, 2023 | Injection Needle, REF: 25207 | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, LUER-lock,0.8mm, REF: 26175PD | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| 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 |
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.