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.
XO Marshmallow Limited Edition Banana Puddin' OMG is being recalled for missing product labels on packaging. The recall affects 526 retail units distributed in 27 U.S. states and internationally.
Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.
Wismettac Asian Foods is recalling Premium Quality Shirakiku Fish Sausage Jalapeno because the casing contains undeclared bovine collagen. The product was distributed across 23 U.S. states.
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.
It'll Be Pizza is recalling Take 2 frozen pizza dough products (1,678 cases) distributed across Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire due to possible contamination with foreign debris from packaging.
Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.
GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.
Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.
Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.
DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United States.
DeRoyal Industries has voluntarily recalled 162 NEURO PACK neurological medical device kits distributed across 23 U.S. states. The reason for the recall was not disclosed by the manufacturer.
DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.
DeRoyal Industries is voluntarily recalling 76 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states. The specific reason for this Class II recall is not detailed in the public notice.
DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.
DeRoyal Industries is recalling 190 cataract procedure packs that contain 3M Health Care Steri Drapes which have been recalled. The affected packs were distributed across 22 US states.
DeRoyal Industries Inc recalled 16 kits of DeRoyal TOTAL HIP PACK (Lot 56042728, expiring May 1, 2026) distributed across 23 U.S. states. The specific reason for the recall was not provided in available agency documentation.
DeRoyal Industries Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.
DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.
DeRoyal Industries Inc has voluntarily recalled shoulder arthroscopy surgical packs distributed across 22 US states. The specific reason for recall was not disclosed in the FDA notification.
DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.
DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.
DeRoyal Industries voluntarily recalled 72 kits of its EYE PACK medical device. The affected lot (Lot 57344921, exp. November 1, 2026) was distributed across multiple U.S. states.
DeRoyal MAJOR ORTHO PACK kits (Ref 89-9250.07) are being voluntarily recalled. The specific reason is not provided in the FDA notice. Affected lots were distributed across 23 U.S. states.
DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.
DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.