Recalls published in November 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in November 2025, newest first.
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Class II · 11 months ago
Medline Sterile Basic EYE Pack 16: 1) REF: Dynj37743D recall: Medline has identified specific sterile eye procedure kits with pouch
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
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Class II · 11 months ago
Medline convenience kits labeled as: 1) Minor Single Basin Pack recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Elekta Solutions Ab Mosaiq Oncology Information System Software Builds 3.1.3, 3.2.1 recall: When appending a care plan that contains one or more wave medication orders
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the…
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Class II · 11 months ago
Medline convenience kits labeled as: 1) General Laparoscopy recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Exactech, Inc. Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip recall: Due to products that have not completed design updates and performance
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and…
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Plastic Blood Gas Capillary Tubes, 115 ¿L recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Class II · 11 months ago
Thoratec LLC Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System recall: Due to potential corrosion issues associated with the Backup Battery cable
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
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Class II · 11 months ago
Auris Health, Inc Monarch Bronchoscope recall: Potential that product was leak tested with equipment outside of its expected
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible…
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Class II · 11 months ago
Medline convenience kits labeled as: 1) Neuro Craniotomy CDS #36-RF recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Medline convenience kits labeled as: 1) General AAA #11-RF recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Plastic Blood Gas Capillary Tubes, 115 ¿L recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Micro Capillary Blood Collection, 300 ¿L recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Class II · 11 months ago
Medline convenience kits labeled as: 1) Major Laparotomy CDS recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Medline convenience kits labeled as Local Basic, REF Dynj34418M recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Sterilmed, Inc. Brand Name: Acuson, Catheter Acunav Diagnostic Ultrasound 8FR recall: Affected catheters were reprocessed beyond validated cycles
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead…
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Class II · 11 months ago
Thoratec LLC Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit recall: Due to potential corrosion issues associated with the Backup Battery cable
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
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Class II · 11 months ago
Beckman Coulter Inc. DxFLEX Flow Cytometer recall: Due to a software error code that crashes during acquisition on patient
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to…
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Class II · 11 months ago
Berkeley Advanced Biomaterials, LLC Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI recall: Due to incorrect product label (Incorrect product name identified on outer
Due to incorrect product label (Incorrect product name identified on outer packaging).
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Micro Capillary Blood Collection, 200 ¿L recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill Magnetic Rings for Safe-T-Fill Blood Gas recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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Class II · 11 months ago
Becton Dickinson & Company BD Luer Tip Caps recall: BD has confirmed through internal testing that certain device trays failed
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
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Class II · 11 months ago
Medline convenience kits labeled as: Cath LAB Pacemaker Pack recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker…
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Class II · 11 months ago
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked recall: Due to distributing the measles IgG IVD without a premarket approved/cleared
Due to distributing the measles IgG IVD without a premarket approved/cleared.
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Class II · 11 months ago
Anatomy Supply Partners, LLC. Safe-T-Fill MicroHematocrit Capillary Tubes, 50 ¿L recall: Due to products manufactured under an inadequate quality system to include
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.