FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 8 of 30

Class IIDeviceOngoing
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Philips North America · Cambridge, MA

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 export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

Class IIDeviceOngoing
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLD; 7) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLE; 8) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL5; 9) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL6; 10) MVHS GU GYN ROBOT PACK , Catalog Number: SOTDKGREFB
Class IIDeviceOngoing
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A
Class IIDeviceOngoing
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
Class IIDeviceOngoing
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano Corp · San Diego, CA
Class IIDeviceOngoing
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM) Software Version: n/a Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures. Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of regional anesthesia. Component: surgical kits
Class IIDeviceOngoing
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Percussionaire Corporation · Sandpoint, ID
Class IIDeviceOngoing
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
American Nitrile Operations Llc · Grove City, OH
Class IDeviceOngoing
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED
Class IIDeviceOngoing
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System
Class IIDeviceOngoing
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;
Class IIDeviceOngoing
Computed Tomography X-ray System, Model: uCT 550 with software
Shanghai United Imaging Healthcare Co., Ltd. · Shanghai
Class IIDeviceOngoing
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Shanghai United Imaging Healthcare Co., Ltd. · Shanghai
Class IIDeviceOngoing
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R11, R12 and R13;
Class IIDeviceOngoing
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI , Catalog Number: PGVMDVB27; 5) KIT,GU DAVINCI , Catalog Number: PGVMDVB28; 6) KIT,GU DAVINCI , Catalog Number: PGVMDVB29; 7) COLORECTAL PACK , Catalog Number: SBA73CLKFD; 8) COLORECTAL PACK , Catalog Number: SBA73CLK26
Class IIDeviceOngoing
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Philips North America Llc · Cambridge, MA
Class IIDeviceOngoing
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No
Class IIDeviceOngoing
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Shanghai United Imaging Healthcare Co., Ltd. · Shanghai
Class IIDeviceOngoing
Computed Tomography X-ray System, Model: uCT 780 with software
Shanghai United Imaging Healthcare Co., Ltd. · Shanghai
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Oct 7, 2026 · Z-3313-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0018-2027

Cardinal Health 200, LLC · Waukegan, IL

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 impact can range from user dissatisfaction to the potential for the user of slip and fall.

Reported Oct 7, 2026 · Z-3297-2026

SPECTRUM MEDICAL SRL · Mirandola

Due to blood-to-glycol leak in the heat exchanger.

Reported Oct 7, 2026 · Z-3328-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0012-2027

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0028-2027

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0038-2027

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0003-2027

American Contract Systems Inc · Tiffin, OH

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 contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).

Reported Oct 7, 2026 · Z-3294-2026

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Reported Oct 7, 2026 · Z-3276-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0029-2027

Custom Interventional Pain Management, LLC · San Antonio, TX

Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.

Reported Oct 7, 2026 · Z-0067-2027

Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation

Reported Oct 7, 2026 · Z-3322-2026

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 infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.

Reported Oct 7, 2026 · Z-3289-2026

Medline Industries, LP · Northfield, IL

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, melting, burning, or fire. Additional products added to 11/26/2025 recall.

Reported Oct 7, 2026 · Z-3227-2026

Penumbra Inc. · Alameda, CA

Due to manufacturing issues reperfusion catheters may fracture.

Reported Oct 7, 2026 · Z-3331-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0035-2027

Philips North America · Cambridge, MA

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 export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

Reported Oct 7, 2026 · Z-3308-2026

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, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Reported Oct 7, 2026 · Z-3278-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0045-2027

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, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Reported Oct 7, 2026 · Z-3284-2026

Philips North America · Cambridge, MA

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 export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

Reported Oct 7, 2026 · Z-3318-2026

Cardinal Health 200, LLC · Waukegan, IL

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 impact can range from user dissatisfaction to the potential for the user of slip and fall.

Reported Oct 7, 2026 · Z-3296-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0009-2027

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0020-2027

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0040-2027

The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.

Reported Oct 7, 2026 · Z-3155-2026

ASP Global, LLC. · Austell, GA

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.

Reported Oct 7, 2026 · Z-0033-2027

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, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Reported Oct 7, 2026 · Z-3287-2026

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, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Reported Oct 7, 2026 · Z-3280-2026