The Recall Desk

State

New Jersey product recalls

73,100 recalls have nationwide distribution and so reach New Jersey. 9,767 additional recalls listed New Jersey specifically in their distribution scope.

What the numbers show

Total
9,767
Critical
1,249
Severe
2,486
Most recent
2026-09-25

Of the 9,767 recalls naming New Jersey we have scored against our rubric, 1,249 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,486 (25%) are Severe.

These figures cover only the 9,767 recalls whose distribution notice names New Jersey specifically. The 73,100 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

10201–10225 of 82867

  • HighFDA (Devices)·Z-3243-2024·2024-10-02

    Medical device kit recalled due to inability to confirm sterilization assurance

    American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.

    Product
    Cysto, FTCY03L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2024·2024-10-02

    Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery

    Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.

    Product
    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3198-2024·2024-10-02

    Philips Ingenia Ambition X MRI Scanner Recalled Due to Loose Screws

    Philips is recalling 63 units of the Ingenia Ambition X MRI scanner due to loose screws in the IRF carrier assembly that may block the imaging tabletop and potentially delay diagnosis.

    Product
    Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3267-2024·2024-10-02

    Boston Scientific esophageal stents recalled due to catheter tip detachment risk

    Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.

    Product
    WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3259-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug units expire before labeled date

    Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date

    Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3286-2024·2024-10-02

    WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3283-2024·2024-10-02

    Wallflex and Agile Esophageal Stent Systems Recalled for Potential Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.

    Product
    WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3284-2024·2024-10-02

    Esophageal Stent Systems Recalled Due to Catheter Detachment Risk

    Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3216-2024·2024-10-02

    ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error

    Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.

    Product
    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3293-2024·2024-10-02

    Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment

    Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.

    Product
    AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3298-2024·2024-10-02

    Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration

    CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.

    Product
    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3245-2024·2024-10-02

    FDA Recalls Surgical Instrument Handle That May Break During Use

    The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.

    Product
    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3264-2024·2024-10-02

    Stryker TMJ Unilateral Implant Recalled Due to Incorrect Components

    TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.

    Product
    Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3201-2024·2024-10-02

    Philips MR 5300 MRI System Recalled for Loose Assembly Screws

    Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.

    Product
    MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2024·2024-10-02

    Prescription immunosuppressant tablets recalled due to failed dissolution specifications

    Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

    Product
    MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3275-2024·2024-10-02

    Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk

    Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3199-2024·2024-10-02

    MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment

    Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2024·2024-10-02

    MRI Diagnostic Device Screws May Loosen, Block Tabletop

    Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.

    Product
    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1829-2024·2024-10-02

    M&P Food Vareniki Products Recalled for Undeclared Wheat

    M&P Food Productions is recalling Potato & Mushroom Vareniki because the products contain undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPC: 707163026174
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3191-2024·2024-10-02

    Custom Procedure Kit Sheath Introducers Mislabeled by Size

    Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.

    Product
    Custom Procedure Kit, REF: K12T-11077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2024·2024-10-02

    Philips MR 7700 MRI Scanner Recall for Loose Screws

    Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.

    Product
    MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3224-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.

    Product
    Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3281-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.

    Product
    WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3294-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 units distributed worldwide.

    Product
    AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide