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.
The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.
Oregon Tool is recalling about 29,560 log splitters and cylinder kits because the hydraulic cylinder rod can separate from the piston, causing unexpected movement of the wedge that poses injury risks. No injuries have been reported.
JAKKS Pacific is recalling certain Mario Kart 24V Ride-On Racer Cars because the acceleration pedal can become clogged with debris and stick, causing the vehicle to crash. The company has received 65 reports of clogged pedals, including 15 crashes with one minor injury.
Crosman is recalling about 2,500 Icon Air Rifles because an uncocked and loaded rifle can discharge unexpectedly if jolted or dropped, posing an injury hazard. One unintended discharge has been reported, though no injuries have occurred.
Chau River Sports Outdoors is recalling about 200 kids' bike helmets sold on Temu.com because they fail to meet federal safety requirements and may not protect children's heads in a crash.
Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
Mak Trading Co. Ltd. is recalling MK Cinnamon Powder (45g) for elevated lead contamination. The affected product was distributed to four retailers in California.
Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.
Canadian Art Prints is recalling Tranquility & Teachings plate sets that may exceed FDA guidance levels for leachable lead. The recall affects 83 boxes distributed across 14 U.S. states.
Philips has recalled 143 Ingenia 1.5T CX MRI systems due to potential incorrect installation of the patient support table floor plate affecting worldwide distribution.
Philips is recalling 49 Achieva XR magnetic resonance imaging systems worldwide due to an incorrectly installed patient support table floor plate that may affect equipment stability and patient safety.
Weis Markets is recalling Peanut Butter Filled Iced Donuts due to foreign material (metal) found in the product. Affected donuts were distributed at a retail store in Pennsylvania with sell-by dates between March 15–18, 2024.
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.
Philips is recalling Intera 1.5T magnetic resonance systems worldwide because the patient support table floor plate may be incorrectly installed, potentially affecting table stability and patient safety.
Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.
Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.
Philips Ingenia 3.0T CX MRI systems may have an incorrectly installed patient support table floor plate. This installation error could compromise the stability of the patient support table during use.
Philips is recalling 448 Ingenia Elition X MRI systems worldwide due to potentially incorrect installation of the patient support table floor plate, which could compromise structural integrity.
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.