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.
Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
McKesson is recalling Gemcitabine Injection (1 g per 26.3 mL) due to temperature abuse—the product was stored at controlled room temperature instead of under refrigeration. The affected lot was distributed nationwide.
Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.
Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.
Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.
Bard Access Systems is recalling Poly Midline Catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.
Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.
Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.
Accord Healthcare is recalling Levothyroxine Sodium Tablets 300 mcg (90-tablet bottles) nationwide due to subpotency. The affected lot is D2401522 with expiration date 06/2026.
Blaine Labs Inc is recalling vite20 Antifungal Cream (10% Undecylenic Acid) because the manufacturer discontinued required stability testing for products still on the market within expiration dates.
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.