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.
BANH Ba Xa Lady Cake (260g) was recalled due to undeclared egg allergen. Approximately 222,320 bags distributed across 31 U.S. states may pose risk to egg-allergic consumers.
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 internationally.
A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.
Howmedica Osteonics Corp. is recalling X3 Triathlon inserts due to potential breaches in sterile packaging. The breach could compromise device sterility and allow contamination if the affected units are used.
Aesculap Inc has recalled Hasson trocar surgical instruments (18 units) because sterile blister packaging may be damaged and sterility compromised. The recall affects the U.S. (Kansas, New Jersey, New York) and Canada.
Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.
FGP Manufacturing recalls Frios Gourmet Pops due to undeclared sulfites in frozen popsicles distributed to franchise owners across 17 states. Consumers with sulfite sensitivity should not consume the product.
Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.
FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.
Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.
FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
Bakery by Frothy Monkey is recalling Ham & Cheese Croissants due to potential metal fragments in the product. Consumers should not consume affected units.
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.
A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.
FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.
A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.
Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.
FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.