Recalls published in September 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in September 2025, newest first.
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Class II · 1+ years ago
AVID Medical, Inc. Halyard, CPT Basic IR Pack recall: Potential for open header bag seals, compromising sterility
Potential for open header bag seals, compromising sterility.
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Class II · 1+ years ago
Waldemar Link GmbH & Co. KG LinkSymphoKnee System, Tibial Component recall: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
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Class II · 1+ years ago
Boston Scientific Encore 26 Inflation Device recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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Class II · 1+ years ago
Merit Medical Systems, Inc. 10Fore Hemostasis Valve recall: Due to a manufacturing issue involving the silicone quad ring where the ring
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the…
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Class II · 1+ years ago
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical recall: Retroactive; Due to complaints, labeling correction for permanent
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would…
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Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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Class II · 1+ years ago
Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device recall: Failure of fusion system instruments in the field
Failure of fusion system instruments in the field.
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Class II · 1+ years ago
Boston Scientific UroMax Ultra Kit, Material Numbers : 1. M0062251200 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Boston Scientific Corporation Preventive Maintenance Kit Icefx recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: FA S Altivate Reverse recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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Class II · 1+ years ago
Seaspine Orthopedics Corporation Reef TA Inserter recall: Inserter, used as part of a system with an intervertebral body fusion device
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper…
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Class II · 1+ years ago
AVID Medical, Inc. Halyard, ENT PACK recall: Potential for open header bag seals, compromising sterility
Potential for open header bag seals, compromising sterility.
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Class II · 1+ years ago
Orthofix U.S. LLC Pillar SA Ti, Sterile, 37mm x 28mm x 18mm , 20-degrees recall: A 37 mm implant width intervertebral body fusion device has a labeling
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap…
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Class I · 1+ years ago
Olympus Corporation of the Americas ViziShot 2FLEX. Single Use Aspiration Needle recall: Potential for undetected, deformed a-traumatic tips
Potential for undetected, deformed a-traumatic tips.
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Class II · 1+ years ago
Quidel Corporation QuickVue recall: Dipstick strep A test has potential for false positive results
Dipstick strep A test has potential for false positive results.
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Class II · 1+ years ago
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked recall: Measles IgM Test Kit lacks premarket approval or clearance
Measles IgM Test Kit lacks premarket approval or clearance.
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Class II · 1+ years ago
Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular, Software 8.0.0.4 recall: Software issue that results in the display of outdated information
Software issue that results in the display of outdated information.
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Class II · 1+ years ago
Siemens Medical Solutions USA, Inc Artis Pheno. Image-Intensified Flouroscopic X-Ray recall: Limited system movements after startup
Limited system movements after startup .
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Class II · 1+ years ago
Boston Scientific Corporation ICEfx Cryoablation System recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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Class II · 1+ years ago
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers recall: Two new potential laser safety failure modes have been identified
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The…
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Class II · 1+ years ago
Boston Scientific NephroMax Kit, Material Numbers : 1. M0062101180 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Major Pharmaceuticals and Rugby Laboratories Sulfamethoxazole and Trimethoprim recall: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…