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.
Konges Sløjd Baby Mirror Activity Toys are being recalled because the mirror can detach from the silicone cover, exposing sharp edges that pose a laceration risk to children. About 85 units were sold in the United States.
Crye Precision is recalling LRB Leg Loops because the buckle can loosen and slip when worn with a load-rated belt, creating a fall hazard. About 300 units are affected.
Zeltiq Aesthetics is removing 703 CoolCurve ZELTIQ vacuum applicators due to increased complaints of Paradoxical Hyperplasia reported between 2019 and 2021.
SCIENCE & BIO MATERIALS has recalled ComposiTCP 30 Interference screws due to mislabeling. The recall affects 72 units distributed nationwide in the US.
DePuy Orthopaedics is recalling Modular Cathcart Hip Ball prostheses (sizes 41-60mm) because the Instructions for Use and Surgical Technique Guide did not document a +5mm offset specification. Updated guides now clarify this for hemi-hip arthroplasty procedures.
Premier Research Labs is recalling AloePro Aloe Vera dietary supplement nationwide due to product spoilage visible when opened. Consumers should discontinue use.
Invacare Corporation is recalling 179 Platinum 5NXG Oxygen Concentrator units distributed across 18 states because product labels are missing the required "Rx Only" statement.
Agilent Technologies is recalling 63 Anti-FITC-AP CISH Accessory Kits due to incorrect expiration dates on substrate vial labels, which may result in the use of expired materials.
Goodman Food Products is recalling GOODMAN GLUTEN FREE Vegan Apple Pie due to undeclared cinnamon in products with lot numbers 22088, 22089, and 22118. The recall affects North Carolina, South Carolina, and New Jersey.
Spectranetics' Philips LAS-100 Laser System (105 units) may fail to start if the device detects an inoperable hardware component during power-up, requiring manual error code clearing before operation.
Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.
Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were distributed nationwide.
DePuy Spine is recalling 61 units of the EIT CIF cage spinal fusion device due to a labeling mismatch. The outer carton label does not match the labels on the blister packages and patient information labels.
DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.
Macleods Pharma USA Inc is recalling Eszopiclone 1 mg tablets due to shortfill—customers reported one to three missing tablets from 30-count bottles. Affected lot BEK2009A (exp. 11/2023) was distributed nationwide and to Puerto Rico.
Golden State Medical Supply is recalling 31,260 bottles of Enalapril Maleate Tablets due to manufacturing practice deviations.
Wedgewood Village Pharmacy LLC is recalling Doxycycline oral suspension (10 mg/ml, 60 ml bottles) nationwide due to insanitary conditions and lack of processing controls discovered during FDA inspection.
Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.
Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.
Wedgewood Village Pharmacy is recalling Bethanechol Chloride 1mg/ml suspension (lot 000-03715131) due to insanitary conditions and lack of processing controls observed during an FDA inspection.
Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.
Domino Foods Inc is recalling 3,150 bags of 50-pound Domino Light Brown Sugar (product number 403350) due to potential exposure to extraneous material during manufacturing. Affected lots were distributed in NY, NJ, PA, and RI.
Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.
Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.
Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.