State
73,187 recalls have nationwide distribution and so reach New York. 12,939 additional recalls listed New York specifically in their distribution scope.
Of the 12,939 recalls naming New York we have scored against our rubric, 1,511 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3,148 (24%) are Severe.
Which agencies issued them
These figures cover only the 12,939 recalls whose distribution notice names New York specifically. The 73,187 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
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.
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Howmedica Osteonics is recalling tibial inserts due to potential breaches in sterile packaging. The breach could allow device contamination and increase post-operative infection risk.
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.
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.
Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.
Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.
BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.
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.
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.
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.
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.