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.
The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cakes because they may contain mold before the expiration date.
POM Medical LLC is recalling 5,610 procedural oxygen masks because the re-breather bag may not inflate or the oxygen line may pop off due to a clogged port.
Taro Pharmaceuticals is recalling 5,190 bottles of Children's Ibuprofen Oral Suspension because small particles of inert plastic may be present.
The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cake - Vanilla due to potential mold growth before the expiration date.
Taro Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.
Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Taro Pharmaceuticals is recalling 5,280 bottles of Children's Ibuprofen Oral Suspension due to the presence of small inert plastic particles.
Centurion Medical Products Corporation is recalling 200 Port Access Infusion Kits with 1-inch needles distributed in Illinois due to a supplier-initiated recall.
Blue Bell Creameries is recalling specific lots of Butter Crunch Ice Cream due to possible foreign material in the product.
Anewmed Corporation is recalling 1,749 medical devices because the contract sterilizer lacked adequate packaging data to support the 2-year shelf life.
Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.
Apotex Inc. is recalling specific bottles of Atorvastatin Calcium 40 mg tablets because a single Pravastatin 40 mg tablet was found inside one bottle.
Taro Pharmaceuticals is recalling specific lots of Children's Ibuprofen Oral Suspension because they may contain small particles of inert plastic introduced during manufacturing.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Mylan Pharmaceuticals is recalling 4,272 bottles of Prasugrel 5 mg tablets because they failed to meet dissolution specifications.
Taro Pharmaceuticals is recalling 639,325 bottles of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.
OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.
Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Centurion Medical Products Corporation is recalling 240 Port Full Access Tray kits in Illinois due to a supplier-initiated recall of GRIPPER Needles.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.
OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.