The Recall Desk

State

New Jersey product recalls

72,992 recalls have nationwide distribution and so reach New Jersey. 9,761 additional recalls listed New Jersey specifically in their distribution scope.

What the numbers show

Total
9,761
Critical
1,249
Severe
2,484
Most recent
2026-09-25

Of the 9,761 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 2,484 (25%) are Severe.

These figures cover only the 9,761 recalls whose distribution notice names New Jersey specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7826–7850 of 82753

  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2025·2025-03-26

    CYSTO Model SACY80R Recall for Sterilization Assurance Failure

    American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.

    Product
    CYSTO , Model No SACY80R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2025·2025-03-26

    DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues

    American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.

    Product
    DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0289-2025·2025-03-26

    FDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide

    Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.

    Product
    CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2025·2025-03-26

    Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

    Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.

    Product
    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2025·2025-03-26

    Neuro IR Tray recalled over unconfirmed sterilization assurance

    American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.

    Product
    NEURO IR TRAY , Model No WENI56J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2025·2025-03-26

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.

    Product
    Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2025·2025-03-26

    CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect

    Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2025·2025-03-26

    PICC Line Catheters Recalled for Sterilization Assurance Issues

    American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.

    Product
    CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1357-2025·2025-03-26

    General Laparoscopic Pack Recall Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.

    Product
    GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2025·2025-03-26

    Medical Device Sterilization Assurance Recall: MAJOR DIEP Surgical Kits

    American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.

    Product
    MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2025·2025-03-26

    CO2 Sampling Lines May Fail to Disconnect During Neonatal Care

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0280-2025·2025-03-26

    Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications

    Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2025·2025-03-26

    Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube

    Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2025·2025-03-26

    Labor and Delivery Pack Recalled Over Unconfirmed Sterilization

    American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.

    Product
    LABOR & DELIVERY PACK, Model Nos LLLD19H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2025·2025-03-26

    Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance

    American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.

    Product
    VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2025·2025-03-26

    BD Pyxis Medication Dispensing Systems Software Sync Error Recall

    BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.

    Product
    BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2025·2025-03-26

    Labor and Delivery System Recalled for Sterilization Assurance Issue

    American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.

    Product
    LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2025·2025-03-26

    Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.

    Product
    LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0277-2025·2025-03-26

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels

    Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2025·2025-03-26

    Laceration Tray Kits Recalled Due to Sterilization Assurance Failure

    American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.

    Product
    LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
    Category
    Medical Device
    Distribution
    Distributed nationwide