Medical DeviceOct 7, 2026
Penumbra System recall — FDA Z-3331-2026
Due to manufacturing issues reperfusion catheters may fracture.
Class IIFDA: OngoingPenumbra Inc.
October 2026 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceOct 7, 2026
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants recall — FDA Z-3227-2026
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking,…
Class IFDA: OngoingMedline Industries, LP
Medical DeviceOct 7, 2026
Performance Pro recall — FDA Z-3289-2026
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to…
Class IIFDA: OngoingAmerican Nitrile Operations LLC
Medical DeviceOct 7, 2026
Percussionaire Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C recall — FDA Z-3322-2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of…
Class IIFDA: OngoingPercussionaire Corporation
Medical DeviceOct 7, 2026
Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Mastisol Skin recall — FDA Z-0067-2027
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Class IIFDA: OngoingCustom Interventional Pain Management, LLC
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW recall — FDA Z-0029-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Volcano Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA recall — FDA Z-3276-2026
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Class IIFDA: OngoingVolcano Corp
Medical DeviceOct 7, 2026
American Contract Systems Medical convenience kits containing BD CliniClean Pericare Wipes recall — FDA Z-3294-2026
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a…
Class IIFDA: OngoingAmerican Contract Systems Inc.
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE recall — FDA Z-0003-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
ASP Global DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum recall — FDA Z-0038-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED recall — FDA Z-0028-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE recall — FDA Z-0012-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recall — FDA Z-3328-2026
Due to blood-to-glycol leak in the heat exchanger.
Class IIFDA: OngoingSPECTRUM MEDICAL SRL
Medical DeviceOct 7, 2026
Cardinal Health 200 Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) recall — FDA Z-3297-2026
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The…
Class IIFDA: OngoingCardinal Health 200, LLC
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE recall — FDA Z-0018-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Philips MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software recall — FDA Z-3313-2026
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM…
Class IIFDA: OngoingPhilips North America
Medical DeviceOct 7, 2026
MPR SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) recall — FDA Z-0060-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Percussionaire Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009 recall — FDA Z-3325-2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of…
Class IIFDA: OngoingPercussionaire Corporation
Medical DeviceOct 7, 2026
Shanghai United Imaging Healthcare Co Computed Tomography X-ray System, Model: uCT 530 with recall — FDA Z-3277-2026
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study,…
Class IIFDA: OngoingShanghai United Imaging Healthcare Co., Ltd.
Medical DeviceOct 7, 2026
Merit Medical Systems Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF recall — FDA Z-3305-2026
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceOct 7, 2026
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W recall — FDA Z-3327-2026
Due to blood-to-glycol leak in the heat exchanger.
Class IIFDA: OngoingSPECTRUM MEDICAL SRL
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE recall — FDA Z-0037-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Expressaire DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE recall — FDA Z-0022-2027
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Class IIFDA: OngoingASP Global, LLC.
Medical DeviceOct 7, 2026
Philips Ingenia 3.0T and 3.0T CX recall — FDA Z-3309-2026
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM…
Class IIFDA: OngoingPhilips North America
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.