Medical DeviceDec 25, 2024
Kirwan Surgical Products Optikon Bipolar Pencil 25 Gauge Straight recall — FDA Z-0660-2025
Potential for the outer stainless-steel tube to break or detach.
Class IFDA: OngoingKirwan Surgical Products, LLC
December 2024 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceDec 25, 2024
MEDLINE INDUSTRIES, LP - Northfield HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 recall — FDA Z-0698-2025
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceDec 25, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5 recall — FDA Z-0709-2025
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Class IIFDA: OngoingMint Medical GmbH
Medical DeviceDec 25, 2024
Medtronic Neurosurgery Exacta External Drainage and Monitoring System: 27581 KIT 27581 recall — FDA Z-0662-2025
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Class IFDA: OngoingMedtronic Neurosurgery
Medical DeviceDec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz recall — FDA Z-0686-2025
The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially…
Class IIFDA: OngoingPhilips North America LLC
Medical DeviceDec 25, 2024
K-Systems T47 Warming Plate recall — FDA Z-0689-2025
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm…
Class IIFDA: OngoingCooperSurgical, Inc.
Medical DeviceDec 25, 2024
GE OEC Medical Systems OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile recall — FDA Z-0704-2025
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class IIFDA: OngoingGE OEC Medical Systems, Inc.
Medical DeviceDec 25, 2024
Atlan A300XL recall — FDA Z-0668-2025
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Class IFDA: OngoingDraeger Medical, Inc.
Medical DeviceDec 25, 2024
MEDLINE INDUSTRIES, LP - Northfield HUDSON RCI mBrace, ET Tube Holder with 4 Point Head recall — FDA Z-0697-2025
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceDec 25, 2024
MicroPort Orthopedics EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF recall — FDA Z-0699-2025
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Class IIFDA: OngoingMicroPort Orthopedics Inc.
Medical DeviceDec 25, 2024
GE OEC Medical Systems OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile recall — FDA Z-0703-2025
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class IIFDA: OngoingGE OEC Medical Systems, Inc.
Medical DeviceDec 25, 2024
K-Systems G85 Mini Incubator recall — FDA Z-0688-2025
The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm…
Class IIFDA: OngoingCooperSurgical, Inc.
Medical DeviceDec 25, 2024
Spacelabs Healthcare Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable recall — FDA Z-0684-2025
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the…
Class IIFDA: OngoingSpacelabs Healthcare, Ltd.
FoodDec 25, 2024
Rise Baking Company, LLC dba The New French Bakestone Brothers Pita Bread, 6 Whole Wheat recall — FDA F-0310-2025
Foreign Material (metal)
Class IIFDA: TerminatedRise Baking Company, LLC dba The New French Bakery Inc.
FoodDec 25, 2024
Stuyvers Bread Pull apart Holiday Rolls recall — FDA F-0300-2025
Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
Class IIFDA: TerminatedStuyvers Bread (Premium Brand Bakery Division)
FoodDec 25, 2024
Ocean Group SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB SALMON recall — FDA F-0298-2025
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
Class IIFDA: TerminatedOcean Group Inc.
FoodDec 25, 2024
FoodDec 25, 2024
Compass Minerals Bulk salt product shipped in 1 metric ton tote recall — FDA F-0286-2025
foreign material
Class IIFDA: TerminatedCompass Minerals America Inc.
FoodDec 25, 2024
Stuyvers Bread Baguette, Artisan Multigrain recall — FDA F-0301-2025
Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
Class IIFDA: TerminatedStuyvers Bread (Premium Brand Bakery Division)
FoodDec 25, 2024
Indianapolis Fruit Company Cucumbers Slices 1/2 Cup, 100 cups per case, Product Code recall — FDA F-0374-2025
potential for salmonella
Class IFDA: TerminatedIndianapolis Fruit Company, Inc.
FoodDec 25, 2024
Terry and Joe Baker Farms, LLC dba Baker Farms Baker Farms CURLY MUSTARD 16 oz NET WT 16 oz recall — FDA F-0302-2025
The firm was notified by the Texas Department of Agriculture that the product test positive for Listeria monocytogenes.
Class IFDA: TerminatedTerry and Joe Baker Farms, LLC dba Baker Farms
DrugDec 25, 2024
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml) recall — FDA D-0141-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
Class IIFDA: TerminatedKeystone Industries
DrugDec 25, 2024
Keystone Industries Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL recall — FDA D-0143-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
Class IIFDA: TerminatedKeystone Industries
DrugDec 25, 2024
Olanzapine Tablets, USP 2.5 mg, 30-count bottle recall — FDA D-0154-2025
Failed Impurities/Degradation Specifications
Class IIFDA: OngoingMacleods Pharmaceuticals Ltd
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.