Loading Legacy
Safety · Official FDA Data
Recent medical device recalls reported to the FDA, from monitors and implants to home health equipment.
Orthofix U.S. LLC
Product: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA recall #Z-2729-2026 · Ongoing
Boston Scientific Corporation
Product: Rapid Refill Continuous Injection System, UPN M00566001
Reason: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
FDA recall #Z-2725-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Reason: 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.
FDA recall #Z-2682-2026 · Ongoing
Papablic Inc
Product: Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Reason: Potential for brush heads to break.
FDA recall #Z-2734-2026 · Ongoing
Papablic Inc
Product: Papablic Replacement Brush Heads. Model Number: Papablic18B
Reason: Potential for brush heads to break.
FDA recall #Z-2733-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
Reason: 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.
FDA recall #Z-2685-2026 · Ongoing
ICU Medical, Inc.
Product: ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
FDA recall #Z-2723-2026 · Ongoing
Daavlin Distributing Company
Product: Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
FDA recall #Z-2744-2026 · Ongoing
GE Medical Systems, LLC
Product: Optima XR200amx, Mobile Digital-Ready Radiographic System
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
FDA recall #Z-2726-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
Reason: 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.
FDA recall #Z-2683-2026 · Ongoing
Olympus Corporation of the Americas
Product: Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA recall #Z-2720-2026 · Ongoing
Oscor Inc.
Product: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Reason: 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.
FDA recall #Z-2678-2026 · Ongoing
Daavlin Distributing Company
Product: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
FDA recall #Z-2742-2026 · Ongoing
GE Medical Systems, LLC
Product: Optima XR220amx, Mobile Digital-Ready Radiographic System
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
FDA recall #Z-2727-2026 · Ongoing
Argon Medical Devices, Inc
Product: General Biospy Tray, REF: GUTS1000
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA recall #Z-2706-2026 · Ongoing
Tosoh Bioscience Inc
Product: ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
Reason: The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
FDA recall #Z-2746-2026 · Ongoing
Olympus Corporation of the Americas
Product: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA recall #Z-2718-2026 · Ongoing
Olympus Corporation of the Americas
Product: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA recall #Z-2721-2026 · Ongoing
Argon Medical Devices, Inc
Product: Arterial Line Kit 20ga x 6, REF: 400115A
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA recall #Z-2708-2026 · Ongoing
Daavlin Distributing Company
Product: Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason: Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
FDA recall #Z-2743-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Reason: 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.
FDA recall #Z-2692-2026 · Ongoing
Argon Medical Devices, Inc
Product: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA recall #Z-2704-2026 · Ongoing
Oscor Inc.
Product: Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Reason: 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.
FDA recall #Z-2679-2026 · Ongoing
ICU Medical, Inc.
Product: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
FDA recall #Z-2724-2026 · Ongoing
Argon Medical Devices, Inc
Product: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA recall #Z-2705-2026 · Ongoing
Orthofix U.S. LLC
Product: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA recall #Z-2731-2026 · Ongoing
Medline Industries, LP
Product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Reason: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
FDA recall #Z-2736-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Reason: 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.
FDA recall #Z-2689-2026 · Ongoing
Orthofix U.S. LLC
Product: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA recall #Z-2732-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
Reason: 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.
FDA recall #Z-2686-2026 · Ongoing
Medtronic Perfusion Systems
Product: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA recall #Z-2739-2026 · Ongoing
Argon Medical Devices, Inc
Product: T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA recall #Z-2707-2026 · Ongoing
Abiomed, Inc.
Product: ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Reason: 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.
FDA recall #Z-2688-2026 · Ongoing
Maquet Cardiovascular, LLC
Product: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Reason: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
FDA recall #Z-2741-2026 · Ongoing
GE Medical Systems, LLC
Product: Optima XR240amx, Mobile Digital Radiographic System
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
FDA recall #Z-2728-2026 · Ongoing
Orthofix U.S. LLC
Product: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Reason: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA recall #Z-2730-2026 · Ongoing
Olympus Corporation of the Americas
Product: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA recall #Z-2719-2026 · Ongoing
Medline Industries, LP
Product: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
Reason: Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
FDA recall #Z-2737-2026 · Ongoing
Intuitive Surgical, Inc.
Product: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Reason: Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
FDA recall #Z-2722-2026 · Ongoing
Medtronic Perfusion Systems
Product: Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA recall #Z-2738-2026 · Ongoing
Data source: U.S. Food & Drug Administration (FDA) — openFDA enforcement API. See our methodology.