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.
OneSource Specialty Pharma Limited is recalling one lot of Methohexital Sodium for Injection due to failed impurities and degradation specifications. The affected product was distributed nationwide.
Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.
Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP active pharmaceutical ingredient in three package sizes due to current good manufacturing practice (cGMP) deviations. The product was distributed in California and Florida.
ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.
Encore Medical is recalling EMPOWR 3D KNEE insertion instruments because some packages contain incorrect product sizes due to a packaging discrepancy.
Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (16 oz bottles, Lot 250306B3) nationwide because the product is subpotent. Consumers should stop using the affected product and contact their healthcare provider if they have health concerns.
CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.
Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.
QuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL compounded drug vials due to failed impurities and degradation specifications. The recall affects multiple lot numbers distributed nationwide.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (1 US Gallon) nationwide due to subpotency. The voluntary recall affects specific lot numbers manufactured before the expiration date.
Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.
Medline Industries is recalling Anesthesia Kit Peds (Model DYNJAP10125A, Lot 24JBR072) nationwide because they contain Covidien Mon-a-Therm temperature probes affected by a distribution control error.
Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (32 oz bottles, Lot 250218B3) distributed nationwide because the product is subpotent—containing less active ingredient than labeled.
Nissan is recalling certain 2020–2026 Nissan Armada and 2011–2027 Infiniti QX56/QX80 vehicles with 22" wheels because the Gross Axle Weight Rating on the certification label is incorrect, which can allow the vehicle to be overloaded and increase crash risk.
Wise Foods Inc is recalling Wise Onion Rings, 3.75 oz packages, because they contain undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3 food colorings that are not listed on the label.
Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.
Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.
Klowen Braces is recalling 3 units of the KL Owen Custom Orthodontic Solution (model CIAS-800033) due to a product error that may cause incorrect bracket placement.
Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.
Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (32 oz.) due to subpotency. Affected lots 250206B1, 250218B2, and 250507B1 were distributed nationwide in the US.
Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.
Vista MAX dietary supplement contains undeclared Yellow #5 dye. Consumers allergic to or sensitive to Yellow #5 should not consume the product.
Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.
Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.