Medical device recalls
1,617 recent medical device recalls in our current data.
Showing 1–200, newest first.
FDA Class II · Medical device · October 14, 2026
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an…
Company / brand: Intellijoint Surgical recalls
Affected product: Intellijoint Navigation System recall status
Official ID Z-0119-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a docum…
Company / brand: Steris recalls
Affected product: HexaVue Focus Integration System recall status
Official ID Z-0118-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Company / brand: LeMaitre Vascular recalls
Affected product: TufTex¿ Over-the-Wire Embolectomy Catheter recall status
Official ID Z-0117-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: T1 Patient Monitor recall status
Official ID Z-0116-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: cPM Series Patient Monitor recall status
Official ID Z-0115-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: Passport Series Patient Monitor recall status
Official ID Z-0114-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: BeneView Series recall status
Official ID Z-0113-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: Panorama and Telemetry Monitoring System recall status
Official ID Z-0112-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: BeneVision Series Telemetry Monitor recall status
Official ID Z-0111-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: BeneVision N1 and N-Series Patient Monitor recall status
Official ID Z-0110-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Company / brand: Mindray DS USA recalls
Affected product: ePM Series Patient Monitor recall status
Official ID Z-0109-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio…
Company / brand: Canon Medical System recalls
Affected product: Alphenix INFX-8000C/B5 recall status
Official ID Z-0108-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be fo…
Company / brand: POLYMEDCO recalls
Affected product: SEDIPLAST recall status
Official ID Z-0107-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: ABD HYSTERECTOMY recall status
Official ID Z-0106-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: GYN LAPAROSCOPY PACK recall status
Official ID Z-0105-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: MAJOR PACK recall status
Official ID Z-0104-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: UROLOGY MAJOR recall status
Official ID Z-0103-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: HEART PREP TRAY recall status
Official ID Z-0102-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: DAVINCI LAP/GYN recall status
Official ID Z-0101-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: PLASTICS TRAY recall status
Official ID Z-0100-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: LAPAROSCOPIC PROSTATECTOMY recall status
Official ID Z-0099-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: ROBOTIC PROSTATECTOMY PACK recall status
Official ID Z-0098-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: PACK OPEN HEART CFH recall status
Official ID Z-0097-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: CRANIOTOMY PACK recall status
Official ID Z-0096-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: ENDOVASCULAR PACK recall status
Official ID Z-0095-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: ADULT HEART TRAY SHANDS JACKS recall status
Official ID Z-0094-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: GYN LAPAROSCOPY/LAPAROTOMY recall status
Official ID Z-0093-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Company / brand: AVID Medical recalls
Affected product: DAVINCI TRUCUSTOM BUNDLE recall status
Official ID Z-0092-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Company / brand: Onkos Surgical recalls
Affected product: Onkos Surgical Inc recall status
Official ID Z-0091-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Company / brand: Onkos Surgical recalls
Affected product: Onkos Surgical Inc recall status
Official ID Z-0090-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds…
Company / brand: Nihon Kohden America recalls
Affected product: Product Name recall status
Official ID Z-0089-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in o…
Company / brand: Medtronic MiniMed recalls
Affected product: Brand Name recall status
Official ID Z-0088-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…
Company / brand: Medline Industries recalls
Affected product: Rollator recall status
Official ID Z-0087-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…
Company / brand: Medline Industries recalls
Affected product: Rollator recall status
Official ID Z-0086-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization,…
Company / brand: Stryker Sustainability Solutions recalls
Affected product: BARD EP XT DECAPOLAR STEERABLE recall status
Official ID Z-0085-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to us…
Company / brand: Beckman Coulter recalls
Affected product: DxC 500 AU Clinical Chemistry Analyzers recall status
Official ID Z-0084-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use …
Company / brand: Beckman Coulter recalls
Affected product: DxC 500i Clinical Analyzer Modules recall status
Official ID Z-0083-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Potential for false negative patient results.
Company / brand: DRG International recalls
Affected product: Sperm Ab ELISA recall status
Official ID Z-0082-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s…
Company / brand: Safeguard US Operating recalls
Affected product: Battle Bandage recall status
Official ID Z-0081-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Lack of 510(k) clearance.
Company / brand: Limitless Cryo Spa recalls
Affected product: Glypto Device recall status
Official ID Z-0080-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the pati…
Company / brand: Cardinal Health 200 recalls
Affected product: Presource Packs containing Medtronic Microstream Components recall status
Official ID Z-0079-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
Company / brand: PHILIPS MEDICAL SYSTEMS recalls
Affected product: Spectral CT and Spectral CT 7500 RT recall status
Official ID Z-0078-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
Company / brand: GRI Medical & Electronic Technology Co recalls
Affected product: HALYARD Laparoscopy Comprehensive Pack II REF recall status
Official ID Z-0077-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
Company / brand: QUANTUM OPS recalls
Affected product: Brand Name recall status
Official ID Z-0076-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Biological Steam Test Pack Model/Catalog Number recall status
Official ID Z-0075-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Biological Steam Test Pack Model/Catalog Number recall status
Official ID Z-0074-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall status
Official ID Z-0073-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number recall status
Official ID Z-0072-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall status
Official ID Z-0071-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential…
Company / brand: Steris recalls
Affected product: VERIFY Biological/Integrator Challenge Pack Model/Catalog Number recall status
Official ID Z-0070-2027 ·
Official record ↗
FDA Class III · Medical device · October 14, 2026
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
Company / brand: Medical Action Industries recalls
Affected product: Generic Name recall status
Official ID Z-0069-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
The potential for falsely elevated results.
Company / brand: Siemens Healthcare Diagnostics recalls
Affected product: Atellica CH Revised C-Reactive Protein (RCRP) recall status
Official ID Z-3335-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve…
Company / brand: Wright Medical Technology recalls
Affected product: CHARLOTTE CLAW Screw recall status
Official ID Z-3334-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to incorrect inside packaging label for eyepiece.
Company / brand: Karl Storz Endoscopy recalls
Affected product: HOPKINS Telescope 30¿ recall status
Official ID Z-3333-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the …
Company / brand: Beckman Coulter Mishima K.K recalls
Affected product: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 RE recall status
Official ID Z-3332-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to manufacturing issues reperfusion catheters may fracture.
Company / brand: Penumbra recalls
Affected product: Brand Name recall status
Official ID Z-3331-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle …
Company / brand: Tandem Diabetes Care recalls
Affected product: Brand Name recall status
Official ID Z-3330-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall status
Official ID Z-3329-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to blood-to-glycol leak in the heat exchanger.
Company / brand: SPECTRUM MEDICAL SRL recalls
Affected product: Brand Name recall status
Official ID Z-3328-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to blood-to-glycol leak in the heat exchanger.
Company / brand: SPECTRUM MEDICAL SRL recalls
Affected product: Brand Name recall status
Official ID Z-3327-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.
Company / brand: Micro Therapeutics recalls
Affected product: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code recall status
Official ID Z-3326-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Intrapulmonary Percussive Ventilation recall status
Official ID Z-3325-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Travel Air recall status
Official ID Z-3324-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Impulsator recall status
Official ID Z-3323-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Intrapulmonary Percussive Ventilation recall status
Official ID Z-3322-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Intrapulmonary Percussive Ventilation recall status
Official ID Z-3321-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: In-Line Valve recall status
Official ID Z-3320-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o…
Company / brand: Percussionaire recalls
Affected product: Intrapulmonary Percussive Ventilation recall status
Official ID Z-3319-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Evolution upgrade 1 recall status
Official ID Z-3318-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Upgrade to MR 7700 recall status
Official ID Z-3317-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Upgrade dStream recall status
Official ID Z-3316-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: SmartPath to MR 7700 recall status
Official ID Z-3315-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: SmartPath to dStream for 1 recall status
Official ID Z-3314-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: MR 7700 recall status
Official ID Z-3313-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: MR 5300 recall status
Official ID Z-3312-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Ingenia Elition S and Ingenia Elition X recall status
Official ID Z-3311-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Ingenia Ambition S and Ingenia Ambition X recall status
Official ID Z-3310-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Ingenia 3 recall status
Official ID Z-3309-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Ingenia 1 recall status
Official ID Z-3308-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Philips North America recalls
Affected product: Ingenia Blue Seal SE and Blue Seal XE recall status
Official ID Z-3307-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Company / brand: NOXBOX recalls
Affected product: NOxBOXi Nitric Oxide Delivery System recall status
Official ID Z-3306-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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, whi…
Company / brand: Merit Medical Systems recalls
Affected product: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall status
Official ID Z-3305-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Potential for monomer liquid leakage.
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: PALACOS MV pro 40 recall status
Official ID Z-3304-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Potential for monomer liquid leakage.
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: PALACOS MV+G pro 40 recall status
Official ID Z-3303-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Potential for monomer liquid leakage.
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: PALACOS R+G pro 40 recall status
Official ID Z-3302-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Potential for monomer liquid leakage.
Company / brand: Heraeus Medical (Dental Division) recalls
Affected product: PALACOS R pro 40 recall status
Official ID Z-3301-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus M3 Gold Autoclavable Lateral Telescope 70 recall status
Official ID Z-3300-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Company / brand: Olympus of the Americas recalls
Affected product: Olympus M3 Gold Autoclavable Foroblique Telescope 30 recall status
Official ID Z-3299-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 fl…
Company / brand: Cardinal Health 200 recalls
Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status
Official ID Z-3298-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 fl…
Company / brand: Cardinal Health 200 recalls
Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status
Official ID Z-3297-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 fl…
Company / brand: Cardinal Health 200 recalls
Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status
Official ID Z-3296-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 fl…
Company / brand: Cardinal Health 200 recalls
Affected product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets recall status
Official ID Z-3295-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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. U…
Company / brand: American Contract Systems recalls
Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status
Official ID Z-3294-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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. U…
Company / brand: American Contract Systems recalls
Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status
Official ID Z-3293-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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. U…
Company / brand: American Contract Systems recalls
Affected product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall status
Official ID Z-3292-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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…
Company / brand: American Nitrile Operations recalls
Affected product: Brand Name recall status
Official ID Z-3291-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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…
Company / brand: American Nitrile Operations recalls
Affected product: Brand Name recall status
Official ID Z-3290-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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…
Company / brand: American Nitrile Operations recalls
Affected product: Brand Name recall status
Official ID Z-3289-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3288-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3287-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3286-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3285-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3284-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Positron Emission Tomography and Computed Tomography System recall status
Official ID Z-3283-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3282-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3281-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3280-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3279-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3278-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 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 …
Company / brand: Shanghai United Imaging Healthcare Co recalls
Affected product: Computed Tomography X-ray System recall status
Official ID Z-3277-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Company / brand: Volcano recalls
Affected product: Philips IntraSight Plus REF recall status
Official ID Z-3276-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E0…
Company / brand: Bard Peripheral Vascular recalls
Affected product: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number recall status
Official ID Z-3275-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Company / brand: Alere San Diego recalls
Affected product: Fisher Scientific Sure-Vue Urine hCG recall status
Official ID Z-3274-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Company / brand: Alere San Diego recalls
Affected product: Fisher Scientific Sure-Vue Urine hCG Strip recall status
Official ID Z-3273-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Company / brand: Alere San Diego recalls
Affected product: Fisher Scientific Sure-Vue Serum/Urine hCG recall status
Official ID Z-3272-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Company / brand: Alere San Diego recalls
Affected product: McKesson CONSULT hCG Urine Cassette recall status
Official ID Z-3271-2026 ·
Official record ↗
FDA Class III · Medical device · October 7, 2026
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Company / brand: HeartSine Technologies recalls
Affected product: HeartSine samaritan PAD (Public Access Defibrillator) recall status
Official ID Z-3270-2026 ·
Official record ↗
FDA Class I · Medical device · October 7, 2026
Potential cracks in the hose, which could lead to leakage or the hose falling off.
Company / brand: Draeger recalls
Affected product: VentStar Resus Neo recall status
Official ID Z-3252-2026 ·
Official record ↗
FDA Class I · Medical device · October 7, 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, spar…
Company / brand: Medline Industries recalls
Affected product: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED recall status
Official ID Z-3228-2026 ·
Official record ↗
FDA Class I · Medical device · October 7, 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, spar…
Company / brand: Medline Industries recalls
Affected product: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall status
Official ID Z-3227-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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 t…
Company / brand: Philips North America recalls
Affected product: Philips Medical Systems Technologies Ltd recall status
Official ID Z-3155-2026 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server wit…
Company / brand: Illumina recalls
Affected product: NovaSeq 6000Dx including DRAGEN Server recall status
Official ID Z-0068-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Company / brand: Custom Interventional Pain Management recalls
Affected product: Brand Name recall status
Official ID Z-0067-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0066-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0065-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0064-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0063-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0062-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0061-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0060-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0059-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0058-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0057-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0056-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0055-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0054-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0053-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0052-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0051-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0050-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0049-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0048-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0047-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0046-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0045-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0044-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0043-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0042-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0041-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0040-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0039-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0038-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0037-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0036-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0035-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0034-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0033-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0032-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0031-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0030-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0029-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0028-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0027-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0026-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0025-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0024-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0023-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0022-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0021-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0020-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0019-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0018-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0017-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0016-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0015-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0014-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0013-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0012-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0011-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0010-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0009-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0008-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0007-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0006-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0005-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0004-2027 ·
Official record ↗
FDA Class II · Medical device · October 7, 2026
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…
Company / brand: ASP Global recalls
Affected product: Brand Name recall status
Official ID Z-0003-2027 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3269-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3268-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3267-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3266-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Company / brand: Medline Industries recalls
Affected product: Medline Convenience Kits recall status
Official ID Z-3265-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Company / brand: Baxter Healthcare recalls
Affected product: PRO+ 40" MRS SURFACE recall status
Official ID Z-3264-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Company / brand: Baxter Healthcare recalls
Affected product: PRO+ 36" MRS SURFACE recall status
Official ID Z-3263-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product spec…
Company / brand: Baxter Healthcare recalls
Affected product: PRO+ MRS SURFACE FOR VERSACARE recall status
Official ID Z-3262-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Company / brand: AVID Medical recalls
Affected product: Halyard IV START KIT NON-STERILE recall status
Official ID Z-3261-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Company / brand: AVID Medical recalls
Affected product: Halyard IV START KIT NON-STERILE recall status
Official ID Z-3260-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Gowns do not consistently meet the minimum liquid-barrier performance required.
Company / brand: New York Embroidery Studio recalls
Affected product: New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall status
Official ID Z-3259-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Company / brand: INTERVASCULAR recalls
Affected product: Cardioroot Woven Collagen Coated Vascular Graft recall status
Official ID Z-3258-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devic…
Company / brand: Baxter Healthcare recalls
Affected product: Brand Name recall status
Official ID Z-3257-2026 ·
Official record ↗
Sources last checked October 22, 2026 at 12:00 PM UTC.