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.
Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.
Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.
Dymski Pierogi LLC recalled 836 units of Potato-Cheddar-Broccoli Pierogi products due to undeclared milk allergen. Products were distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.
DYMSKI PIEROGI LLC is recalling Potato & Cheddar Cheese Pierogi products sold in NJ, MA, and PA because they contain undeclared milk and wheat allergens. Consumers with allergies to milk or wheat should not consume these products.
Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.
MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.
Dymski Pierogi LLC is recalling Cheese & Scallion Pierogi (Grandma's Cuisine brand) due to undeclared milk. The product was distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.
Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
Dymski Pierogi LLC is recalling Potato & American Cheese Pierogi products because they contain undeclared milk. The recall affects products distributed in New Jersey, Massachusetts, and Pennsylvania.
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
Cherry Coca-Cola Zero Sugar in 12 oz cans were mislabeled as regular Cherry Coca-Cola and failed to declare phenylalanine on the label, a concern for people with phenylketonuria.
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.
Dymski Pierogi LLC is recalling Sweet Cheese Pierogi products with undeclared milk and wheat allergens. Approximately 1,721 units were distributed to retail and food service locations in NJ, MA, and PA.
Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes distributed nationwide.
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponges (REF DYK1000TSE) are being recalled due to microbial contamination identified on certain lots. The affected product was distributed in the US and Panama.
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.
Off Grid Trailers is recalling 2021-2022 Expedition, Pando, and Switchback travel trailers because damaged burner control valves may cause a gas leak.
Clek is recalling Olli and Ozzi booster seats because a required installation diagram is missing, which could lead to improper installation and increased injury risk in a crash.
Kawasaki is recalling 2020-2022 LX230 motorcycles because an incorrect front brake rotor may have been installed, reducing brake performance and increasing crash risk.
Mack Trucks is recalling certain 2021-2022 tractor trailers due to steering gears that may fracture, causing loss of steering control and crash risk.