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.
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Gaws Gourmet Foods recalls Gaw's XL Ham & Cheese sub sandwiches due to undeclared sesame, a major allergen. The recall affects 357 units distributed in Michigan.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend because the product contains kratom, an unapproved food additive, and has a pH level exceeding the required maximum for acidified products.
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Gaws Gourmet Foods is recalling Gaw's Salami & Cheese Bagel 6oz due to undeclared sesame allergen. Affected products have use-by dates from November 28 through December 15, 2023.
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.
Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.
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.
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.
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.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
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.
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.
Burn Boot Camp AFTERBURN grass-fed whey protein bars (Triple Chocolate with Almond Butter) are being recalled due to foreign material including disposable hairnet, shrink wrap, and parchment paper found in some units. Affected lots are 181, 184, and 187.
Gaws Gourmet Foods is recalling Gaw's Classic Italian sub due to undeclared sesame. The recall affects 699 units distributed in Michigan; consumers who are allergic to sesame should not consume the product.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.