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.
Smith & Nephew is recalling HEALICOIL RSB SA absorbable suture anchors because improper packaging seals may breach the sterile barrier.
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.
Smith & Nephew is recalling OSTEORAPTOR 2.3 W 1UB II BLUE absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer due to CGMP deviations and potential sub-potent ethanol levels.
Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.
ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent a proper seal.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.
Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.
Smith & Nephew is recalling TWINFIX AB 5.0 Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
Genesis Partnership Company SA is recalling 15,000 bottles of Genesis Hand Sanitizer Gel due to manufacturing deviations in a facility that produced sub-potent products.
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.