Recalls published in December 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in December 2025, newest first.
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Class II · 10 months ago
Waldemar Link GmbH & Co. KG Endo Model Knee Fusion Nail SK, Knee Fusion Nail recall: The device has been delivered with a preassembled locking screw that had
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral…
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Class II · 10 months ago
Medline Industries, LP Dexlock Achilles Repair Implant Kits, Makt4520 recall: There have been multiple complaints of drill bit fusing to the bushing/sleeve
There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit…
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Class II · 10 months ago
Stryker MV3 bariatric bed recall: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close…
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Class II · 10 months ago
Medline Industries, LP Curad Quick Strip Fabric Bandages Containing 30 Bandages recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class II · 10 months ago
Stryker Arise 1000EX mattress recall: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX
Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close…
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Class II · 10 months ago
GE Medical Systems, LLC Senographe Pristina, Pristina Serena, and Pristina Serena 3D recall: Some Senographe Pristina systems either have a missing or an incorrect X-Ray
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR…
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Class II · 10 months ago
Bard Peripheral Vascular Inc Safe-T-Centesis 6 Fr Catheter Drainage Tray recall: Acute drainage catheters, indicated for use in removing fluid during acute
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that…
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Construx" Mini PTC Spacer System Product Name: Construx" recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class II · 10 months ago
Medline Industries, LP CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Construx" Mini Ti Spacer System Product Name: Construx" recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class I · 10 months ago
Draeger, Inc. ErgoStar CM 40 Model/ recall: Multiple complaints were reported in which cracks formed in the hose
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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Class II · 10 months ago
Philips North America Azurion R3.0 recall: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The…
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Class II · 10 months ago
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class II · 10 months ago
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class I · 10 months ago
Draeger, Inc. ErgoStar CM 45, Model/ recall: Multiple complaints were reported in which cracks formed in the hose
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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Class II · 10 months ago
C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm recall: Labeling discrepancy; Ureteral stent actual size may not match the actual
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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Class II · 10 months ago
Datascope Corp. Cardiosave Hybrid. Intra-Aortic Balloon Pump system recall: The IFU addendum revises the Preventative Maintenance schedule to align
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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Class I · 10 months ago
Draeger, Inc. ErgoStar CM 60, Model/ recall: Multiple complaints were reported in which cracks formed in the hose
Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.
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Class II · 10 months ago
Cardinal Health 200, LLC ChemoPlus gowns: Product Code recall: Affected gowns have the incorrect expiration date on the product packaging
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the…
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Class II · 10 months ago
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline recall: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise…
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Class II · 10 months ago
Beckman Coulter, Inc. Access 2 Reaction Vessels, individual, disposable recall: It has been determined that certain lots of Access 2 Reaction Vessels
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction…
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Class II · 10 months ago
C.R. Bard Inc Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 recall: Labeling discrepancy; Ureteral stent actual size may not match the actual
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class II · 10 months ago
C.R. Bard Inc BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm recall: Labeling discrepancy; Ureteral stent actual size may not match the actual
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.