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.
Starkey Water is recalling 300 cases of 16.9 oz glass bottles of Starkey Spring Water because 12 ppb of arsenic was detected in a water sample.
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices because they lack 510(k) clearance for a design modification.
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.
Novum Pharma is recalling Novacort Gel sample packets because the pramoxine hydrochloride content was found to be out of specification.
Exactech is recalling 79 Novation Cemented Plus Femoral Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs).
Advanced Sterilization Products is recalling 107 EVOTECH Endoscope Cleaner and Reprocessor Systems because a hose may come loose and cause a leak.
Merge Healthcare is recalling Merge Eye Station software versions 11.6.0 and prior due to a risk of accidental patient record deletion.
Baxter Healthcare is recalling 3,528 units of Premasol Sulfite-Free Amino Acid Injection due to yellow discoloration caused by a damaged overpouch.
In2Bones is recalling 26 units of NEOVIEW Screws Set due to dimensional non-conformity of the thread on the screw head.
In2Bones is recalling 19 locking screws from the NEOVIEW Plating System due to dimensional non-conformity of the thread on the screw head.
Siemens Medical Solutions is recalling Biograph mCT Flow 40-4R scanners because laser cover windows may fall off.
Piazza Produce, Inc. is recalling three sizes of Cajun seasoning because the product labels do not list ingredients. The recall affects food service establishments in five states.
Straumann Manufacturing is recalling 165 dental implant drills because they cannot be inserted into handpieces due to tolerance specification failures.
Siemens is recalling IMMULITE 2000 Intact PTH assay kits because they may show a negative bias of up to -39% at low concentrations.
ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.
GE Healthcare is recalling OEC 9900 Elite and other mobile fluoroscopy systems because the workstation power cable assembly can fail intermittently.
Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.
Siemens Medical Solutions is recalling Biograph mCT-X scanners because laser cover windows may fall off.
Brainlab AG is recalling specific femoral and tibial cutting block adapter bases because they may contain incorrect material, making them unsuitable for reprocessing.
Piazza Produce is recalling Herb De Provence in three sizes because the product labels do not list ingredients. The recall affects food service establishments in five states.
Piazza Produce, Inc. is recalling two sizes of curry powder because the product labeling does not contain a listing of ingredients.
Implant Direct Sybron Manufacturing is recalling 14 units of GoDirect Screw-Retaining Top (Part No. 4500-61) because they were shipped with incorrect labels for a different product.
Siemens Medical Solutions is recalling 88 Biograph mCT scanners because laser cover windows may fall off.
H-E-B is recalling specific lots of Homestyle White Corn Tortillas because they may contain foreign material, possibly corn husk.
Straumann Manufacturing is recalling 120 units of Twist Drill PRO dental implant accessories because they cannot be inserted into handpieces due to tolerance specification failures.