Browse Device Recalls

1,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,683 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 1,683 FDA device recalls in 2026.

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DateProductReasonClassFirm
Jun 11, 2026 ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
Jun 11, 2026 ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... Class I Abiomed, Inc.
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 Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor 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 Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor 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 medical procedure convenience kit labeled as: HIP CDS-LF, Medline ... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I 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 MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Med... The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochl... Class I 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.
Jun 8, 2026 KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, A product error defect may cause incorrect bracket placement. Class II Klowen Braces
Jun 8, 2026 Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R Surgical dressing manufactured out of specification (greater thickness). Class II ConvaTec, Inc
Jun 8, 2026 ARTIS icono ceiling. Model Number: 11328100. Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place.... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU D... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835;... Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenie... Class I Medline Industries, LP
Jun 5, 2026 Optima XR240amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Jun 5, 2026 Optima XR220amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC
Jun 5, 2026 Optima XR200amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a co... Class II GE Medical Systems, LLC

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.