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.
Gaws Gourmet Foods is recalling Gaw's Deluxe Italian sub sandwiches because sesame was not declared on the label. The recalled products were distributed in Michigan.
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
Ben E Keith Foods is recalling frozen and refrigerated shrimp and other food products that were temperature abused while stored in a food trailer. The products were distributed to food service establishments.
Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.
Audi is recalling 2019-2022 E-Tron vehicles because high-voltage battery modules may overheat and increase fire risk. Dealers will install diagnostic software and replace affected modules at no cost.
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
Sienna Bakery Chocolate Decadent Brownies are being recalled due to undeclared peanuts. Consumers with peanut allergies should not consume this product.
Audi is recalling certain 2023-2024 models because the driver's side airbag may be improperly mounted and fail to restrain occupants correctly in a crash.
The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
Wilcox Premium Salted Caramel Turtle ice cream (3-gallon) may be contaminated with Listeria monocytogenes. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates September 14–November 14, 2024.
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Ben E Keith Foods has recalled 1721 cases of frozen and refrigerated foods that were temperature abused during storage and transit. The temperature-compromised products were distributed to food service operations.
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Ben E Keith Foods is recalling approximately 1,721 cases of multiple frozen vegetable and side-dish products due to temperature abuse during shipment. Consumers should discard affected products.
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.