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.
Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.
TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.
Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.
TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.
Teleflex LLC is recalling 170 units of the Pilling Lowsley Prostatic Retractor due to incomplete pre-cleaning instructions in the user manual. Incomplete instructions may prevent proper sterilization of the surgical instrument.
NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.
Pro-Dex Inc recalls KLS Martin Battery Packs used in surgical screwdrivers due to manufacturing and expiration dates being reversed on sterile pouch labels, causing batteries to appear prematurely expired.
TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.
Husqvarna is recalling about 2,700 Residential 300 Series Snow Blowers because the auger pulley bolt can loosen, causing the drive to unexpectedly engage and potentially collide with users. No injuries have been reported.
Anatox Inc has recalled Sonne's Detoxificant #7 due to elevated lead levels. The voluntary recall affects approximately 2,870 bottles distributed in multiple states.
Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
Homeocare Laboratories is recalling Arnica 7 Cream due to manufacturing standards deviations. The recall affects 2,376 bottles with lot number 2446.
StellaLife VEGA Oral Care Gel is being recalled nationwide due to manufacturing practice deviations. Approximately 38,105 tubes are affected by this voluntary recall.
Philips is recalling DigitalDiagnost C90 diagnostic imaging systems due to a software login issue that may prevent users from logging in to the device. The recall affects 58 units distributed across the U.S. and internationally.
Homeocare Laboratories is recalling SnoreStop Naso Spray Bulk due to current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects product distributed nationwide in 55-gallon drums.
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
Anatox Inc is recalling VIT-RA-TOX Calphonite #38 and Sonne's Calphonite #2 due to elevated lead levels. A total of 6,777 bottles distributed across 27 states are affected.
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.
The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.
Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.
SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.
Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
StellaLife VEGA Oral Care Spray is being recalled for manufacturing deviations. The product was distributed nationwide; consumers should discontinue use of affected lots.