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.
Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel in 1.41 oz and 8 oz packages due to undeclared sub-ingredients in the sunflower butter component. Consumers should not consume the affected product.
Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.
PandaEar Stainless Steel Toddler Cups are being recalled because their exterior solder contains lead levels that exceed federal limits. About 1,600 cups sold on Amazon from May through August 2023 are affected. No injuries have been reported.
ROi CPS LLC is recalling Regard CV PK cardiovascular convenience kits due to insufficient instructions for proper chest drain catheter and tube connection setup. 134 units were distributed in Missouri.
Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.
Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.
Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer because they do not meet established potency standards. Some batches are sub-potent or super-potent, potentially affecting antimicrobial effectiveness or causing irritation.
Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.
Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.
Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.
Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sunflower allergen in the product. Affected products (Lot 081321) were distributed in Iowa and Illinois.
Takumi brand frozen tuna ground meat is being recalled due to bacterial contamination (E. coli, coliforms) and elevated histamine. The product was distributed in CA, NV, TX, and NC in August-September 2021.
Lenovo is recalling about 2,850 USB-C laptop power banks because internal screws can loosen, causing a short circuit and lithium-ion battery overheating. One fire with minimal property damage has been reported.
Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because the sub-ingredients of sunflower butter were not declared on the label. The affected packages were distributed in Iowa and Illinois.
Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.