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.
LimFlow, Inc. is recalling 33 units of the LimFlow Vector, model VT-US-23, over an incorrect expiration date.
Novadoz Pharmaceuticals is recalling three lots of Glycopyrrolate Oral Solution, 1 mg/5 mL, after they failed impurities and degradation specifications.
Canon Medical Systems is recalling 332 Alphenix INFX-8000V systems because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.
Zimmer Surgical is recalling 51 A.T.S. 3200TS Tourniquet Systems because the user interface may freeze or become unresponsive to touch in certain non-English language settings.
Cerapedics is recalling 237 units of PearMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc, over an incorrect expiration date.
Edan Diagnostics is recalling 1,457 units of its iT20 Telemetry Transmitter after an FDA letter raising potential cybersecurity issues with the firm's devices.
Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.
Community Products is recalling 1,096 units of the Rifton Low Base TRAM over potential fraying on the body support strap.
Edan Diagnostics is recalling 3,721 units of its Fetal Monitor models F2 and F3 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System after an FDA letter raising potential cybersecurity issues with the firm's devices.
ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 3,824 units of its Patient Monitor models X8, X10 and X12 after an FDA letter raising potential cybersecurity issues with the firm's devices.
ICU Medical is recalling Plum Duo Precision IV Pumps because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Catao Market is recalling 260 master cases (3,120 loaf cakes) of Mini Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.
Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.
Edan Diagnostics is recalling 13,934 units of its M3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.
Edan Diagnostics is recalling 395 units of its Central Monitoring System models MFM-CNS and MFM-CNS Lite after an FDA letter raising potential cybersecurity issues with the firm's devices.
Catao Market is recalling 775 master cases of Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.
Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.
Edan Diagnostics is recalling 3,518 units of its Fetal & Maternal Monitor models F6, F9, F6 Express and F9 Express after an FDA letter raising potential cybersecurity issues with the firm's devices.
Edan Diagnostics is recalling 12,201 units of its M3A Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.