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.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407511 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360010 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
International Life Sciences is recalling Artelon FlexBand Plus, refs 41054 and 41057, because the augmentation devices failed bacterial endotoxin testing.
Medline is recalling five surgical drape products because the fabric may delaminate prematurely when the included laundering instructions are followed.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Jaguar Land Rover North America is recalling certain 2026 Land Rover Defender vehicles because the third-row lower seat belt anchorage bracket may have an insufficient weld stud, potentially preventing proper restraint during a crash.
Raz Design is recalling several Mobile Shower Commode Chair models because a vendor modification means the seat may be reinstalled without properly engaging the outside rear seat brackets that hold it in place.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407508 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 analyzers after confirmed complaints that GEM PAK cartridges may show increased Process Control Solution Not Detected errors during warm-up.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Lutronic is recalling the CLARITY II Laser System after reports of devices sparking or popping and potentially burning patients.
Willamette Valley Pie Company is recalling Frozen Raw Bulk 9 inch Blueberry Crumble Pie due to potential contamination with listeria monocytogenes. The frozen pies were sold to grocery retailers' in-store bakeries in Illinois and Oregon.
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.
Boston Scientific is recalling EndoVive Safety PEG Kits containing BD ChloraPrep Triple Swabsticks because open or compromised seals on the swabstick packaging could cause loss of sterility.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055407510 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2835/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/09 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.
Palmetto Gourmet Foods Inc. is recalling Vegetarian Chicken Flavor Ramen Express because the product contains undeclared Yellow #5 food coloring, a major allergen for some consumers.
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.