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.
Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.
Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.
Busse Hospital Disposables is recalling SS 3.5MM Pellet Insertion Tray kits nationwide. The kits contain swab products with uncertain manufacturing test method validation.
Busse Convenience kits containing swab and swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about test method validation during manufacturing.
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.
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 Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.
Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer due to storage outside of labeled temperature requirements, which may affect product efficacy.
Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.
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 Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.
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.
Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.
Busse Hospital Disposables is recalling Lumbar Tray units nationwide because test methods used during manufacturing could not be adequately validated. The recall affects swab/swabstick products used in medical procedures.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation. Products were distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the 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.
AMBI Skincare Fade Cream Oily Skin (2 OZ) is recalled nationwide due to improper storage temperature. The product was stored outside the temperature requirements specified on its label.
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.
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 Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.
Busse Convenience kits containing swab products are being recalled due to inadequate validation of manufacturing test methods.
Karben4 Brewing LLC is recalling 644 cases of Wisco Pop Cherry Soda because the soda may contain yeast. Affected lots 030722.01 and 040822.02 were distributed in Illinois, Minnesota, and Wisconsin.
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.
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.