Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.
Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise sterility.
Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.
Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.
Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.
Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.
Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.
LaBree's Bakery is recalling 205 cases of Chocolate Chip Mini Muffins due to the presence of foreign material. The product was distributed in Michigan and New York.
Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.
Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.
GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.
Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.
Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.
Philips is recalling 86 IntelliVue TcG10 monitors because the instructions for use are missing a warning against using the device on patients under gas anesthesia.
Baroody Imports Inc. is recalling 9 cases of Baroody Pickled Labneh with Garlic in New York due to undeclared sorbic acid.
Walgreens Infusion Services is recalling Deferoxamine in normal saline due to a lack of sterility assurance. The products were distributed in six states.
Quest Nutrition is recalling specific lots of QuestBar protein bars because they may contain plastic pieces from an ingredient supplier.
BD Biosciences is recalling two lots of Anti-Lambda APC-H7 antibody due to contamination with CD38 antibody. The product is used for in vitro flow cytometric immunophenotyping.
Arrow International is recalling specific hemodialysis catheterization sets because the tunneling sheath can crack during placement, potentially delaying treatment.
Mylan Institutional is recalling 3,993 cartons of Lamotrigine 200 mg tablets because they were not manufactured according to Good Manufacturing Practices.
Roche Molecular Systems is recalling cobas 4800 KRAS Mutation Test kits because they are generating invalid results for the Mutant Control and/or KRAS Calibrator.
Baroody Imports Inc. is recalling Baroody Pickled Labneh with Pepper because the product contains undeclared sorbic acid and sulfites.
Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.
Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.
Straumann USA is recalling dental implant drill sets that may contain incorrect drills. The recall covers 362 pieces distributed nationwide and internationally.