Recalls published in December 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in December 2025, newest first.
-
Class II · 10 months ago
Brand Name: Diasol Product Name: 100230-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class I · 10 months ago
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer recall: A certain component of affected devices was not delivered within
A certain component of affected devices was not delivered within specification and contained impurities.
-
Class I · 10 months ago
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak recall: Ophthalmic procedure packs may have incomplete seals affecting sterility
Ophthalmic procedure packs may have incomplete seals affecting sterility.
-
Class II · 10 months ago
Brand Name: Diasol Product Name: 100125-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
-
Class II · 10 months ago
Cook Incorporated Ring Transjugular Intrahepatic Access Sets recall: Cook Medical identified that products supplied in the affected device lots
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may…
-
Class II · 10 months ago
Beckman Coulter Bicarbonate REF: OSR6137 OSR6237 OSR6637 OSR6x37 recall: Bicarbonate reagent may generate falsely high Bicarbonate results
Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Brand Name: Diasol Product Name: 100325-10-DEX100 recall: Safety and efficacy of dialysis acid concentrate cannot be assured
Safety and efficacy of dialysis acid concentrate cannot be assured
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Cook Incorporated R¿sch-Uchida Transjugular Liver Access Sets recall: Cook Medical identified that products supplied in the affected device lots
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may…
-
Class II · 10 months ago
Microbiologics Inc Lyfo Disk, Campylobacter jejuni subsp. jejuni derived from Atcc recall: Affected units may fail to recover the target microorganism Campylobacter
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
-
Class II · 10 months ago
Microbiologics Inc Kwik-Stik 6-Pack, Campylobacter jejuni subsp. jejuni derived recall: Affected units may fail to recover the target microorganism Campylobacter
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
-
Class II · 10 months ago
Brand name: Agfa Digital Radiography X- Ray system DR 800 with Musica recall: It is possible to exceed the maximum allowed Air Kerma rate (AKR)
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
ICU Medical, Inc. LifeShield Drug Library Management , LifeShield Infusion Safety recall: Software issue only allows Concentration Limits to be defined to one digit
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001)…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
-
Class II · 10 months ago
Zimmer, Inc. Brand Name: Affixus Antegrade Femoral Nailing System Product Name recall: Affected implants may have undersized distal diameter along length
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…