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.
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.
Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.
Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.
Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.
The JM Smucker Company is recalling Great Value Cinnamon Rolls nationwide due to possible plastic pieces in the product. Consumers should not consume affected units.
Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.
South Shore cribs sold from July 2020 to February 2024 have wider-than-standard slat spacing, creating an entrapment hazard for children. The company is offering full refunds and consumers should stop using the recalled cribs immediately.
About 6,500 Nerf Barrage youth helmets sold at Walmart (2022–2024) are recalled for retention system failures violating federal safety standards. No injuries reported. Consumers should stop using the helmets and contact Todson for a refund.
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.
AVID Medical is recalling Halyard Upper Extremity Pack surgical kits because sponge forceps and towel clamps may shed small metal flakes. These flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Trinity Gold Nutrition capsules (Lot IN-030, expiring November 2027) have been recalled for containing three undeclared pharmaceutical ingredients: acetaminophen, diclofenac, and phenylbutazone. These unapproved drugs could cause health risks through medication interactions and adverse effects.
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.
Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.
AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.