Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
M&P Food Productions is recalling Vareniki, Potato and Mushroom, because the product contains undeclared wheat. Consumers with celiac disease or wheat allergies should not eat the product.
ConMed Corporation is recalling STAT 2 I.V. Gravity Flow Controllers and administration sets because they exhibit inaccurate or inconsistent flow rates.
Avid Medical is recalling 8 TruCustom Pacemaker Packs containing needles with loose polypropylene foreign material.
Avid Medical is recalling 44 TruCustom Minor Procedure kits because the included needles may contain loose polypropylene foreign material.
Elekta Limited is recalling 539 Integrity R1.2 units due to a potential for positional errors following automatic table movement.
Olympus is recalling specific urologic endoscopic working inserts and bridges because adhesive fragments may detach and enter patients during procedures.
NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.
Avid Medical is recalling 90 TruCustom Pacemaker Pack convenience kits because they may contain loose polypropylene foreign material in the included needles.
Cook Inc. is recalling 615 units of Mallinckrodt Institute Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Oakworks Inc. is recalling foot controls for specific medical imaging tables because they can become lodged under the table base or column.
La Salsa Foods Inc. is recalling International Food Court brand Thai Sweet Chili Roasted Pumpkin Seeds due to undeclared soybean oil and soy lecithin.
Avid Medical is recalling 597 TruCustom Ortho Tray kits because they may contain needles with loose polypropylene foreign material.
Otto Bock is recalling 75 Kenevo knee joints due to a design issue that could cause the pylon to break under specific heavy-use conditions.
Ethicon is recalling 25 lots of VICRYL RAPIDE suture because the material failed knot tensile strength testing during quality control.
Zimmer Biomet is recalling 38,879 units of the 2nd Assist Knee Positioner because the sterile packaging barrier may be breached during distribution.
AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.
Accord Media, LLC is recalling 524 Ultra Renew devices distributed nationwide because they use an unapproved green LED light to treat hyperpigmentation.
Topson Downs is recalling Cat & Jack Girls' Star Studded Skinny Jeans because metal stars can detach and cause lacerations. Consumers should stop wearing them and return them to Target for a refund.
Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.
Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.
Philips is recalling 705 Allura Xper systems because Anode Drive Units may fail in high-voltage regions, reducing X-ray performance to emergency mode.
ZOLL Medical Corporation is recalling 46 units of 731 Series Ventilators due to a software anomaly that may allow users to inadvertently change device settings.
Avid Medical is recalling 444 TruCustom CATH PACK kits because they may contain loose polypropylene foreign material in the needles.
Otto Bock is recalling four Kenevo knee joints due to a design issue that could cause the pylon to break, leading to a fall.
Howmedica Osteonics Corp. is recalling 130 AccuLIF TL Insertion Handles because the implant may pivot instead of maintaining a rigid connection when the lever is locked.