The Recall Desk

State

New York product recalls

73,741 recalls have nationwide distribution and so reach New York. 12,955 additional recalls listed New York specifically in their distribution scope.

What the numbers show

Total
12,955
Critical
1,508
Severe
3,701
Most recent
2026-10-28

Of the 12,955 recalls naming New York we have scored against our rubric, 1,508 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3,701 (29%) are Severe.

These figures cover only the 12,955 recalls whose distribution notice names New York specifically. The 73,741 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

36676–36700 of 86696

  • HighFDA (Devices)·Z-0402-2020·2019-11-20

    Orthofix Recalls Elbow Sterile Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Elbow Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0396-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0350-2020·2019-11-20

    PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

    PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

    Product
    Universal Sexual Health Testing Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2020·2019-11-20

    Cadence Science Pressure Control Glass Syringes Recalled for Breakage Risk

    Cadence Science is recalling 237 Pressure Control Glass Syringes because they may break during use, posing a potential injury risk to patients and healthcare workers.

    Product
    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of non-sterile drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0387-2020·2019-11-20

    Orthofix Recalls UE Xcaliber Metadiaphyseal Complete Kits Due to Design Defect

    Orthofix Srl is recalling UE Xcaliber Metadiaphyseal Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0351-2020·2019-11-20

    Smith & Nephew Recalls LAG Screw Guide Pin Sleeves Due to Manufacturing Error

    Smith & Nephew is recalling 116 LAG Screw 3.2mm Guide Pin Sleeves because a manufacturing error prevented the detent balls from fully compressing.

    Product
    LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2020·2019-11-20

    Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0380-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0406-2020·2019-11-20

    Siemens SOMATOM CT Scanner Software Recall for System Crashes

    Siemens Medical Solutions is recalling syngo CT VB20 software for SOMATOM CT scanners due to scan aborts and system crashes.

    Product
    Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2020·2019-11-20

    TriMed Countersink Instruments Recalled Due to Epoxy Coating Defect

    TriMed Inc. is recalling 99 nonsterile 1.7mm countersink instruments because the epoxy coating can pop off. The recall covers nationwide and specific foreign distribution.

    Product
    TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 3.2 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0377-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometric Design Defect

    Orthofix Srl is recalling specific lots of 3.2 mm drill bits because a geometric detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0398-2020·2019-11-20

    Orthofix Recalls Lower Limb Diaphyseal Sterile Kits Due to Drill Bit Design

    Orthofix Srl is recalling specific lots of Lower Limb Diaphyseal Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0386-2020·2019-11-20

    Orthofix Radiolucent Wrist Fixator Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Radiolucent Wrist Fixator Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0532-2020·2019-11-20

    KVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles

    KVK-Tech is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution because black particles were found during inspection.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2020·2019-11-20

    Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect

    Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0374-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0401-2020·2019-11-20

    Orthofix Ankle Transfix Pin Sterile Kit Recalled for Design Defect

    Orthofix Srl is recalling Ankle Transfix Pin Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0388-2020·2019-11-20

    Orthofix Recalls XCaliber Ankle Kits Due to Drill Bit Design Defect

    Orthofix is recalling XCaliber Ankle Complete Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0361-2020·2019-11-20

    Exactech Recalls Fluted Pin Pouches Due to Potential Quantity Error

    Exactech is recalling 2.4mm x 2.5 Fluted Pin Pouches because they may contain one pin instead of four. The recall covers 9 units distributed in four states.

    Product
    2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Diaphyseal Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0362-2020·2019-11-20

    Tec Com TECOTHERM NEO Thermo-Regulation System Recalled for Faulty Peltier Elements

    Tec Com GmbH is recalling five TECOTHERM NEO thermo-regulation systems due to faulty Peltier elements that may fail to maintain temperature control.

    Product
    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is…
    Category
    Medical Device
    Distribution
    Distributed nationwide