Medical device recalls
39231 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-07-22FDA-DeviceAbiomed, Inc.Class IAbiomed Impella RP Flex recalled for sheath leakage risk
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- 2026-07-22FDA-DeviceOscor Inc.Class IAbiomed Impella Introducer Kit recalled for leaking risk
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- 2026-07-22FDA-DeviceOscor Inc.Class IAbiomed Impella introducer sheaths recalled for leakage risk
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- 2026-07-22FDA-DeviceOscor Inc.Class IAbiomed Impella Introducer Kit recalled for leaking risk
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- 2026-07-08FDA-DeviceZimmer Surgical IncClass IIZimmer Surgical tourniquet hoses recalled for sterility breach
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- 2026-07-08FDA-DeviceZimmer Surgical IncClass IIBrand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- 2026-07-08FDA-DeviceW L Gore & Associates, Inc.Class IIGORE TAG thoracic endoprosthesis recalled for catheter separation
Due to catheter separation
- 2026-07-08FDA-DeviceMasimo CorporationClass IIMasimo Radius VSM cuff recalled for false alarms and rough edges
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- 2026-07-08FDA-DeviceMasimo CorporationClass IIMasimo Radius VSM ECG set recalled for false alarms and cuff irritation
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
- 2026-07-08FDA-DeviceLaborie Medical Technologies CorpClass IILaborie Solar GI System recalled for moisture accumulation risk
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Access Systems biopsy trays recalled for defective lidocaine
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Provena Midline Catheters recalled for lidocaine manufacturing defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerPICC catheters recalled for lidocaine quality issue
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Groshong NXT catheter recalled for lidocaine manufacturing defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerPICC Provena catheters recalled for defective lidocaine
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerMidline Catheter recalled for lidocaine manufacturing defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerMidline Catheter recalled for lidocaine manufacturing defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Power-Trialysis dialysis catheters recalled for lidocaine defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Power-Trialysis dialysis catheters recalled for lidocaine defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerPICC SV catheters recalled for lidocaine defects
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard PowerPICC SOLO HF Catheter recalled for defective lidocaine
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard DuoGlide dialysis catheter recalled for defective lidocaine
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Poly Midline Catheter recalled for lidocaine manufacturing defects
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBard Access Systems, Inc.Class IIBard Access Systems drainage trays recalled for lidocaine manufacturing defect
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- 2026-07-08FDA-DeviceBD SWITZERLAND SARLClass IIBD Medline 111 gravity set recalled for engineering sample shipment
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
- 2026-07-08FDA-DeviceCovidien LLCClass IICovidien Shiley decannulation plug recalled for mislabeled DEHP
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
- 2026-07-08FDA-DeviceCarl Zeiss Meditec AGClass IIZeiss Intrabeam radiation applicator recalled for manufacturing defect
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- 2026-07-08FDA-DeviceSiemens Medical Solutions USA, IncClass IISiemens ARTIS icono ceiling monitor recalled for loose screws
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
- 2026-07-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayCare 2024A SP4 recalled for beam delivery note data loss
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
- 2026-07-08FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayCare 2024A SP1 recalled for beam note data loss risk
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
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