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.
Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.
Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.
The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.
The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.
Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.
Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.
FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.
KALO Carrot Cake All Natural Gluten Free is mislabeled with Chocolate Cake ingredient information that omits soy, creating an allergen hazard for consumers with soy allergy.
TRP Natural Eyes Pink Eye Relief sterile eye drops are being recalled due to lack of assurance of sterility. The recall affects 139,656 bottles distributed nationwide.
Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.
Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.
Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths after inadvertently mixing unvalidated devices into production. The recall affects 853 units distributed nationwide.
Optikem International is recalling TRP Natural Eyes Floaters Relief eye drops nationwide due to lack of assurance of sterility in manufacturing. Affected bottles have lot numbers F404, F405, or F406.
TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.
Eugia US LLC is recalling 1,160 vials of Tobramycin for Injection due to failed water determination testing. Affected lot numbers are 3TB23001 and 3TB23002, expiring 04/30/2025.
Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.
Optikem International is recalling TRP Natural Eyes Allergy Eyes Relief eye drops due to lack of assurance of sterility. The recall affects 30,240 bottles distributed nationwide.
Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed blend uniformity specifications. The affected lots (SFBG024, SFBG025) were distributed in Puerto Rico, Tennessee, and Rhode Island.
B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).
TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.
Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.
Capitol Commissary LLC is recalling 1,195 units of Jacksons Egg Salad sandwiches due to potential cross contact with sesame. Consumers with sesame allergies should not consume the affected product.
Capitol Commissary LLC is recalling CK Chicken Salad On A Croissant due to potential cross-contact with sesame. The recall affects 29 units distributed across seven Western states.
Capitol Commissary LLC is recalling Jacksons Chicken Salad On A Croissant due to potential sesame cross contact. The product was distributed in seven western states.