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.
Health One Pharmaceuticals is recalling Target Bullet dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Vege Slim 4 K dietary supplements due to significant violations of cGMP regulations.
Health One Pharmaceuticals is recalling Excelerol dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Siemens Medical Solutions is recalling four Syngo.plaza PACS units because they may leave partially archived studies unarchived during pre-fetch operations.
Health One Pharmaceuticals is recalling 1,438 units of Kidney Tonic due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Newzealand Colostrum Tablets due to significant violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
Health One Pharmaceuticals is recalling Lecithin 100 dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Gamma Zyme dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Reishi Mushroom capsules due to significant violations of dietary supplement manufacturing regulations.
Health One Pharmaceuticals is recalling Shu Chang Bao dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Health One Pharmaceuticals is recalling Motichi dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
Advanced Sterilization Products is recalling Tyvek Rolls with STERRAD Chemical Indicators because they were shipped after their expiration date.
Zimmer Trabecular Metal Technology is recalling one unit of a NexGen femoral augment block that was mislabeled as 5 mm instead of 20 mm.
Matheson, Inc. is recalling Medical Air cylinders in Michigan and Wisconsin because they failed impurity specifications for carbon dioxide.
CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.
Synthes, Inc. is recalling 249 Electric Pen Drive systems because the Hand Switch labels for 'on' and 'lock' were interchanged.
Sunshine Burger & Specialty Food Company is recalling 4,113 packages of Organic Sunshine Burgers because gluten testing revealed levels above 20 ppm in products labeled gluten-free.
Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.
American Specialty Pharmacy is recalling 15 vials of Hydroxocobalamin Injection Solution 1 mg/mL due to the presence of particulate matter and potential preservative issues.
West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.
Sunshine Burger & Specialty Food Company is recalling frozen veggie burgers labeled gluten-free because testing found gluten levels above 20 ppm.
ArthroCare Medical Corporation is recalling 15 Coblator II systems because specific components were reversed on the controller boards.
In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, due to incorrect calibrator values for Phenytoin 2 and Phenobarbital 2 assays.
In2Bones is recalling 35 units of DUAFIT PIP 0o CA Size 2 interphalangeal implants because dimensional non-conformity prevents them from fitting into the dedicated holder.