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.
Philips Incisive CT System foot switch unload pedal may trap an operator's foot, causing injury. The FDA is recalling 5 units (3 in the US, 2 internationally) with this entrapment hazard.
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.
Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. No illnesses have been reported.
Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.
3M is recalling 3M Attest Steam Chemical Integrators manufactured November 2022–January 2023 due to increased potential for ink leakage during sterilization cycles. Approximately 16.2 million units were distributed worldwide.
Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.
Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.
240 units of HydroPICC 4Fr Single Lumen Catheter Maximal Barrier Kits are being recalled because the catheter's actual expiration date is shorter than the date printed on the outer package.
Astral SteriTech has recalled Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. The recall affects 6,127 bottles.
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.
Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.
Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.
Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was distributed nationwide.
Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.
Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.
Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.