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.
GRUVIPA S.L. is recalling CB1102006 BOCATA 120 sandwiches distributed in Florida due to potential insect filth contamination of the finished product.
McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.
McKesson is recalling 9 vials of Duraclon (clonidine HCl) injection nationwide due to temperature deviations that violated current Good Manufacturing Practice (cGMP) standards.
McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.
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.
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.
BMW is recalling certain 2022 X4 vehicles because the tire information label may contain incorrect tire size and pressure information. Installing wrong-sized or improperly inflated tires increases the risk of a crash.
Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.
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.
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.
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.
Baxter Healthcare is recalling 180 APD Drain Manifold units distributed in nine US states because certain product codes lack FDA regulatory clearance. Patients using affected units should contact Baxter Healthcare immediately.
Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.
Busse Hospital Disposables recalls Universal Nerve Block Trays and swab products manufactured by PDI due to uncertainty regarding manufacturing test method validation.
Family Dollar and Johnson & Johnson Consumer are recalling Aveeno Daily Moisturizing Lotion due to cGMP violations involving improper storage temperature. No illnesses have been reported.
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/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 I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.
Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.
Family Dollar is recalling an AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer (SPF 30) for improper storage. The product may have reduced efficacy.
Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.
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.
Busse Hospital Disposables, Inc. is recalling Cervical Tray Catalog 1089 convenience kits due to uncertainty regarding adequate validation of manufacturing test methods. No illnesses or injuries have been reported.