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.
Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.
Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.
Bakery by Frothy Monkey is recalling Spinach & Feta Croissants sold in Tennessee and Alabama due to potential metal fragments. Consumers should not eat these croissants and should return them to the store.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
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.
Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.
Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.
Bakery by Frothy Monkey is recalling chocolate croissants due to the potential presence of metal fragments. The affected products were distributed in Tennessee and Alabama.
Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.
A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
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.
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.
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.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
Rong Shing Trading NY Inc is recalling 4.7oz bottles of Dried Tangerine Plum due to undeclared sulfites. Products distributed in Florida and New York with best-before date 05/31/2023 may be affected.
Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.
Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.
Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.
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.
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.
Bakery by Frothy Monkey is recalling individually packaged Plain Croissants distributed in Tennessee and Alabama (Best By 01/31/2024) due to potential metal fragments.
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
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.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.