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.
McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.
McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.
McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.
McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.
McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.
The Manhattan Toy Company is recalling its Activity Loops toys because tubes can detach from the base and release small plastic rings that pose a choking hazard to children. No injuries have been reported.
Nautilus is recalling about 7,300 treadmills because they can start on their own, creating a fall hazard. No injuries have been reported to date.
Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.
Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.
Family Dollar Stores is recalling AMBI Skincare Even & Clear Exfoliating Wash because the product was stored outside labeled temperature requirements during manufacturing. No illnesses have been reported.
Busse Hospital Disposables recalls Universal Nerve Block Trays and swab products manufactured by PDI due to uncertainty regarding manufacturing test method validation.
Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.
Medline Industries recalls Polyurethane Foam Bedside Cleaning Kits due to sporadic reports of discoloration on foam sponges caused by microbial contamination. The recall affects 22,765 boxes distributed in the US and Panama.
BD Anti-Kappa APC and PE reagents used in flow cytometry testing may exhibit uncharacteristic flow profiles, potentially affecting test accuracy. Worldwide distribution to 249 units across US states and Taiwan.
Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
Busse Convenience kits containing swab and swabstick drug products manufactured by PDI are recalled due to uncertainty about manufacturing test method validation. No illnesses have been reported.
Karben4 Brewing LLC is recalling specific lots of Wisco Pop Ginger Soda because cans may contain yeast. The recall affects products distributed in Illinois, Minnesota, and Wisconsin.
Busse Hospital Disposables is recalling Universal Nerve Block Tray units (catalog 9779) due to uncertainty regarding test method validation in manufacturing the included swab/swabstick drug products. No illnesses or injuries have been reported.
Busse Convenience kits containing medical swabs and sticks have been recalled due to uncertainty about whether the manufacturing test methods used were adequately validated.
Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.
Busse Hospital Disposables is recalling convenience kits containing swab products due to uncertainty about adequate validation of manufacturing test methods.
Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.
MEDLINE has recalled its Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS) in the United States and Panama after sporadic reports of discoloration. The discoloration has been identified as microbial contamination.
Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.