The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

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.

7526–7550 of 52964

  • HighFDA (Devices)·Z-2633-2024·2024-09-04

    Medline procedure packs recalled due to syringe quality issues

    Medline is recalling procedure packs containing Shenli syringes due to leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2753-2024·2024-09-04

    Medline Umbilical Line Kits Recalled Due to Syringe Quality Issues

    Medline is recalling Umbilical Line Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2634-2024·2024-09-04

    Medline recalls medical convenience kits with defective plastic syringes

    Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.

    Product
    Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE E
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V651000·2024-09-04

    2021-2024 Volkswagen ID.4 Door Handles May Fail Due to Water Ingress

    Volkswagen is recalling 2021-2024 ID.4 vehicles because door handles may allow water to enter the circuit board, causing doors to open unexpectedly while driving. Owners should contact Volkswagen dealers for free inspection and repair.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2740-2024·2024-09-04

    Medline Baby Care Kits Recalled Due to Syringe Quality Issues

    Medline is recalling Baby Care Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2763-2024·2024-09-04

    Medline Recalls LEEP and Trab Buckle Kits Due to Syringe Defects

    Medline is recalling specific LEEP and Trab Buckle procedural kits because they contain plastic syringes with leaks or breakage risks.

    Product
    Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2772-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Quality Issues

    Medline is recalling Centurion procedure kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2762-2024·2024-09-04

    Medline procedural kits recalled due to syringe quality issues

    Medline is recalling specific procedural kits because they contain plastic syringes with leaks or breakage risks that may pose a threat to patient health.

    Product
    Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2761-2024·2024-09-04

    Medline Circumcision Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling specific circumcision procedure kits because they contain plastic syringes with identified leaks, breakage, and other quality issues that may pose a risk to patient health.

    Product
    Medline Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT6335; 2) CIRCUMCISION TRAY , Pack Number CIT6135BH; 3) CIRCUMCISION TRAY , Pack Number CIT2465; 4) CIRCUMCISION TRAY , Pack Number CIT4920; 5) CIRCUMCISION TRAY , Pack Number CIT7455; 6) CIRCUMCIS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2734-2024·2024-09-04

    Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts

    Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.

    Product
    CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2745-2024·2024-09-04

    Medline recalls three medical procedure kits with defective plastic syringes

    Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2739-2024·2024-09-04

    Medline pediatric anesthesia circuit kits with defective plastic syringes

    Medline procedural kits contain plastic syringes with leaks, breakage, and quality issues that may pose patient health risks. Affected units have been distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2830-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing defective Sol-M syringes. About 1,756 units were distributed nationwide due to manufacturing defects.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2024·2024-09-04

    Medical procedure packs containing defective syringes recalled by Medline

    Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2777-2024·2024-09-04

    Medline Centurion Procedure Packs Recalled Due to Syringe Quality Issues

    Medline Industries is recalling Centurion procedure packs containing defective Caina syringes due to leaks and breakage risks.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2778-2024·2024-09-04

    Medline Centurion Procedure Packs with Syringes Recalled for Defects

    Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2723-2024·2024-09-04

    Stryker iBur 4.0mm surgical bur recall: excessive heat risk during bone surgery

    Stryker iBur 4.0mm precision surgical burs may overheat where the shank meets the distal bushing. Excessive heat could cause minor tissue damage or thermal injury requiring medical intervention.

    Product
    Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2024·2024-09-04

    Centurion Procedure Packs With Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2764-2024·2024-09-04

    Medline procedural kits recalled for plastic syringe defects

    Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pa
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2759-2024·2024-09-04

    Medline Procedural Kits Recalled for Syringe Quality Defects

    Medline is recalling NEURO TRAY procedural kits (Pack DYNJ55909B, Lot 23IBB122) due to plastic syringe defects including leaks and breakage that may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2024·2024-09-04

    Medline dialysis procedure packs recalled for syringe leaks and breakage

    Medline procedure packs containing Shenli syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall involves 1,679,067 units distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ91
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2724-2024·2024-09-04

    Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall

    Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2024·2024-09-04

    Custom Orthopedic Surgical Implant Does Not Match Design Specifications

    A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.

    Product
    Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2752-2024·2024-09-04

    Medline surgical procedure kits recalled due to defective plastic syringes

    Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
    Category
    Medical Device
    Distribution
    0 states