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.
Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.
La Roche-Posay Effaclar Duo acne treatment is being recalled due to detected trace levels of benzene. The recall affects 2,226,801 units distributed nationwide.
Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Units (Product Number 100506US) due to a high voltage capacitor that may fail early in the device's life cycle, potentially producing smoke, burning smell, spark, or excessive heat.
Wells Enterprises is recalling Glenview Farms Vanilla Flavored Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.
Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model Number 420 due to incorrect labeling of balloon inflation hubs. The inner and outer balloon labels are swapped, which could lead to improper device use.
Wells Enterprises is recalling Mocha Almond Fudge Ice Cream (3-gallon tubs) because plastic fragments may be present in the product. Consumers should not consume the affected product.
L'Oreal USA is voluntarily recalling all lots of La Roche-Posay Effaclar Duo Dual Action Acne Treatment due to detected trace levels of benzene in a specific lot.
Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.
AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.
Wells Enterprises is recalling Keith Valley Vanilla Flavored Ice Cream 3-gallon tubs due to the possible presence of plastic foreign material in the product.
BSO LLC is recalling Testosterone Pellet 100 mg (compounded, office use only) distributed nationwide due to glass particles found in pellet vials.
One lot of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830) was stored at improper temperatures in Medline warehouses. The test kits may not perform as intended due to storage outside labeled requirements.
Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.
Lamb Weston frozen hashbrown patties may contain pieces of plastic material measuring 1–8 mm. The affected product was distributed in Arizona, Hawaii, and several international locations.
Lamb Weston Inc is recalling frozen foodservice hashbrown patties due to plastic pieces (1–8 mm) found in the product. Affected cases were distributed to Arizona, Hawaii, Japan, Kuwait, Taiwan, and UAE.
Bio 1 Granules for Filling implant bone granules may contain less product than specified on the label. The affected lot is 240781 (UDI: 03760154000369), distributed nationwide.
Siddha Flower Essences is voluntarily recalling Temper Tamer homeopathic oral spray due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Remote Diagnostic Technologies Ltd. is issuing a software update for the Philips Tempus Pro Patient Monitor due to freezing, rebooting, and potential ECG measurement accuracy issues across multiple software versions.
Getinge Disinfection Ab recalls the Washer Disinfector Aquadis 56 (Model 56M) because the frequency inverter is not programmed to specification, causing the circulation pump to start earlier than expected and wear the axial seal prematurely.
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.
Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set due to incorrect front pouch labeling that states 5.0/2.2 instead of the correct size 5.6/2.8.
Galt Medical Corporation is recalling GALT Guidewire model SGW-051-07 due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
Tornier's Blueprint Software version 4.2.1 contains a bug that prevents surgeons from accessing surgical cases created in earlier software versions.
Integra LifeSciences is recalling INSPIRA AIR Balloon Dilation System 10x40 cartons because an incorrect product was packaged inside. The recall affects six units distributed across Texas, Montana, Alabama, and Oklahoma.
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% due to a defective container where the spike of the cap becomes lodged in the bottle nozzle, preventing users from accessing the solution.