Browse Device Recalls

35,226 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,226 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 35,226 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jun 11, 2026 Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model... Due to a defective circuit board that overheats Class II Oxos Medical Inc
Jun 11, 2026 Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity P... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64... The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 IQon Spectral CT IQon Spectral CT Upgrades The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to ... Class II PHILIPS MEDICAL SYSTEMS
Jun 11, 2026 FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vas... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vascul... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART M... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline K... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit... Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD Pu... Class II Medline Industries, LP
Jun 11, 2026 FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... Class II Boston Scientific Corporation
Jun 11, 2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that i... Class II Boston Scientific Corporation
Jun 11, 2026 FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculatur... Boston Scientific's complaint investigations have identified that a subset of air ingress complai... Class II Boston Scientific Corporation
Jun 10, 2026 Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0... Software issue that can cause an increase in spontaneous software closures. Class II Foundation Medicine, Inc.
Jun 10, 2026 Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... Class II Medline Industries, LP
Jun 10, 2026 Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... Class II Medline Industries, LP
Jun 10, 2026 Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral ... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 10, 2026 ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infus... In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... Class II ICU Medical, Inc.
Jun 10, 2026 ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) ... In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on ... Class II ICU Medical, Inc.
Jun 10, 2026 Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilatera... Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M10... Class II Orthofix U.S. LLC
Jun 9, 2026 Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console ... Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersec... Class II CMR SURGICAL LIMITED
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
Jun 8, 2026 STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefideroc... Due to incorrect cartridges include in affected products that there is the potential for false-su... Class II Hardy Diagnostics
Jun 8, 2026 STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Lami... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neur... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II Windstone Medical Packaging, Inc.
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French s... Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufact... Class II Medline Industries, LP
Jun 8, 2026 Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atelli... Class II Siemens Healthcare Diagnostics, 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.