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.
Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.
Degania Silicone, Ltd. is recalling Silicone Fluted Round Drain 24Fr and Connector units because sterile pouches are missing labels. The boxes are properly labeled, and only lot P1607442 is affected.
Medtronic is recalling 253 O-arm 1000 mobile X-ray systems to implement a software update that resolves multiple operational and imaging defects.
Toshiba is recalling two INFX-8000H Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Springside Monterey Jack Morel & Leek Cheese is being recalled because it may have been made with milk held for 13.8 seconds during pasteurization.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling 1.2 million LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Cypress Medical Products LLC is recalling specific surgical kits because they do not meet iodine assay requirements for their 36-month expiration dating.
Hospira Inc. is recalling Labetalol Hydrochloride Injection vials because of cracked glass at the rim, which is covered by the stopper and crimp seal.
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Mckesson Packaging Services is recalling Ranitidine Tablets 150 mg due to failed stability specifications. The recall affects 17,192 cartons distributed nationwide.
Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.
Z-Medica is recalling 4,890 units of QuikClot TraumaPad dressings because one pouch in a box was mislabeled as a different product, though the contents were correct.
Stryker is recalling ACL Disposable Pack Bone-Tendon-Bone units because routine testing found bioburden levels higher than internal acceptable rates.
Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.