Medical DeviceAug 20, 2025
Waldemar Link GmbH & Co. KG Plastic Trial Head Brown, 7 mm neck length recall — FDA Z-2289-2025
Inconsistent size terminology and color coding used on labeling
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Latest records
Latest recalls — page 184
The newest recall records with useful source details are listed here.
Medical DeviceAug 20, 2025
Boston Scientific Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding recall — FDA Z-2273-2025
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 20, 2025
Merit Medical Systems High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C recall — FDA Z-2293-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Merit Medical Systems Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 recall — FDA Z-2294-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
Philips Respironics DreamStation Auto CPAP recall — FDA Z-2227-2025
Devices may possess a programming error resulting in an incorrect device configuration.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging recall — FDA Z-2312-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
Carefree Surgical Specialties Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray recall — FDA Z-2281-2025
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Class IIFDA: OngoingCarefree Surgical Specialties
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System recall — FDA Z-2318-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
Merit Medical Systems Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B recall — FDA Z-2295-2025
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the…
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging recall — FDA Z-2320-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging recall — FDA Z-2311-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging recall — FDA Z-2317-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
Waldemar Link GmbH & Co. KG Prosthesis Head B, 28 mm, 7 mm neck length recall — FDA Z-2288-2025
Inconsistent size terminology and color coding used on labeling
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed recall — FDA Z-2309-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
HeartMate Mobile Power Unit, AC Power Cord recall — FDA Z-2290-2025
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended…
Class IFDA: OngoingThoratec LLC
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging recall — FDA Z-2319-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
PERLA ¿ TL MIS CANNULATED FENESTRATED POLYAXIAL SCREW recall — FDA Z-2279-2025
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Class IIFDA: OngoingSPINEART SA
Medical DeviceAug 20, 2025
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray recall — FDA Z-2283-2025
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Class IIFDA: OngoingCarefree Surgical Specialties
Medical DeviceAug 20, 2025
CareFusion 303 Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI recall — FDA Z-2321-2025
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
Class IIIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 20, 2025
GE Medical Systems GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System recall — FDA Z-2310-2025
GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 20, 2025
Philips Respironics DreamStation Auto. Non-Continuous Ventilator recall — FDA Z-2229-2025
Devices may possess a programming error resulting in an incorrect device configuration.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 20, 2025
Philips Respironics DreamStation Auto BiPAP recall — FDA Z-2228-2025
Devices may possess a programming error resulting in an incorrect device configuration.
Class IFDA: OngoingPhilips Respironics, Inc.
Medical DeviceAug 20, 2025
Instrumentation Laboratory HemosIL LMW Heparin Controls recall — FDA Z-2323-2025
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceAug 20, 2025
Trinity Biotech USA Bartels ELISA Legionella Urinary Antigen recall — FDA Z-2292-2025
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
Class IIFDA: OngoingTrinity Biotech USA
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
September 2026361 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categoriesOctober 2025455 records · 4 categories