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.
Sato Pharmaceutical is recalling 3,640 bottles of INON ACE Antacid tablets after the lot failed disintegration specifications, taking longer than expected.
Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
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.
LimFlow, Inc. is recalling 33 units of the LimFlow Vector, model VT-US-23, over an incorrect expiration date.
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.
Medline is recalling procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
Keurig Dr Pepper is recalling 960 cartons of McCafe Premium Roast Decaf Coffee K-Cup Pods because the product is labeled as decaf but might contain caffeine.
Canon Medical Systems is recalling 98 units of the Alphenix INFX-8000F because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.
Elekta is recalling 5,391 medical linear accelerators, covering Elekta Synergy, Harmony, Infinity and Versa HD, due to a manufacturing issue and electrical grounding of systems.
Canon Medical Systems is recalling 172 units of the Alphenix INFX-8000C because fixing screws of the ceiling movement gear in the ceiling suspended arm may become loose.
Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
Medline is recalling 456 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
Medline is recalling 60 units of the Head Shave-Latex Safe Kit because it contains MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked.
Miach Orthopaedics is recalling 284 BEAR Implants because the label carries an expiration date that extends beyond the product's documented and approved shelf life.
Medline is recalling 40 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
Medline is recalling 66 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
Novadoz Pharmaceuticals is recalling three lots of Glycopyrrolate Oral Solution, 1 mg/5 mL, after they failed impurities and degradation specifications.
Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
CareFusion is recalling 189 BD Alaris Pump Modules, model 8100, because modules flashed with a daylight saving time timestamp may lose connectivity to hospital networks.
Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.
ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.
Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.
Catao Market is recalling 385 master cases of Mini Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.
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.
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.