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.

10101–10125 of 22145

  • HighFDA (Devices)·Z-2982-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling medical convenience kits due to quality issues in plastic syringes, including leaks and breakage that may affect patient safety. Affected products include tracheostomy kits and airway packs distributed worldwide.

    Product
    Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DY
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3106-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline Industries is recalling anesthesia circuit kits due to reported adverse events indicating potential loss of suction during intermittent use. Approximately 29,585 units distributed in the US, Canada, and Panama are affected.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0323C; c) ANESTHESIA CIRCUIT ADULT, Pack Number DYNJAA0378A; d) ADULT ANESTHESIA CIRC LAGUNA, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1805-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods recalls Walmart Original Freshness Guaranteed Macaroni Salad (16oz) distributed in nine U.S. states due to possible foreign material contamination. No illnesses have been reported.

    Product
    UPC 78742 12653, Walmart Original Freshness Guaranteed Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3055-2024·2024-09-18

    Medline Convenience Kits With Syringes Recalled for Quality Defects

    Medline is recalling medical convenience kits containing syringes due to quality issues including leaks and breakage. These defects may pose a risk to patient health and were identified in relation to an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC LOCAL PACK-LF, Pack Number DYNJ54607A ; 3) LOCAL PACK, Pack Number DYNJ61839B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2986-2024·2024-09-18

    Medline medical convenience kits recalled due to syringe quality defects

    Medline is recalling multiple medical convenience kits worldwide that contain plastic syringes with defects that may leak or break, posing a risk to patient safety.

    Product
    Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ; 3) CARDIAC MINOR-LF, Pack Number DYNJ51939; 4) CARDIAC MINOR SURGICOUNT PACK , Pack Number DYNJ56573; 5) PEDIATRIC EP PACKMH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3062-2024·2024-09-18

    Guidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly

    Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.

    Product
    Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Syringes

    Medline Industries recalls numerous sterile procedure kits containing plastic syringes affected by an FDA Safety Alert from March 2024. The syringes may leak or break, posing potential risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3022-2024·2024-09-18

    Medline Convenience Kits with Defective Syringes Recalled Due to Leaks and Breakage

    Medline Convenience kits containing plastic syringes are recalled worldwide due to leaks, breakage, and quality issues posing risks to patients. Multiple lot numbers from 2020–2023 are affected.

    Product
    Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3047-2024·2024-09-18

    Medline convenience kits recalled for syringe leaks and breakage defects

    Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.

    Product
    Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUMCISION TRAY 1.1 , Pack Number CIT6260A ; 4) CIRCUMCISION TRAY 1.3 CM BELL , Pack Number CIT7740; 5) CIRCUMCISION TRAY , Pack Nu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3034-2024·2024-09-18

    Medline Convenience Kits With Syringes Recalled for Leaks and Breakage

    Medline convenience kits containing plastic syringes are being recalled worldwide due to leaks and breakage that may pose patient health risks. The kits are linked to an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ5
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3116-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Suction Loss

    Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3058-2024·2024-09-18

    Medline Biopsy Tray Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline BIOPSY TRAY-LF medical convenience kits (Pack DYNDH1229, Lot 22FBA002) are recalled due to plastic syringe leaks, breakage, and quality issues that may pose risks to patient health.

    Product
    Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1801-2024·2024-09-18

    Pasta Salad Product Recalled Due to Foreign Material Contamination

    Reser's American Classics Garden Pasta Salad (UPC 71117 19063) is being recalled due to potential foreign material contamination. The recall affects 278 cases distributed to nine states.

    Product
    UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3099-2024·2024-09-18

    Spacelabs Ultraview DM4 Monitor Recalled for Inadequate Battery Safety Warnings

    Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.

    Product
    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3100-2024·2024-09-18

    Medical device diagnostic test shows measurement bias in certain samples

    Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.

    Product
    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2997-2024·2024-09-18

    Medline recalls medical convenience kits with defective plastic syringes

    Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.

    Product
    Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3032-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline has recalled convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects multiple lot numbers distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3035-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.

    Product
    Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2984-2024·2024-09-18

    Medline medical convenience kits with defective plastic syringes recalled

    Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3072-2024·2024-09-18

    Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing

    Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.

    Product
    ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3111-2024·2024-09-18

    Medline Suction Liners Recalled for Potential Loss of Suction

    Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Plastic Syringe Quality Issues

    Medline is recalling multiple convenience kits containing defective plastic syringes that may leak or break, posing potential patient health risks. The defective syringes were identified through an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3117-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Suction Loss

    Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3074-2024·2024-09-18

    Syringes with Needles Recalled for Substantial Design Differences from FDA Approval

    Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.

    Product
    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3077-2024·2024-09-18

    SOL-M Syringes with eccentric tips recalled for regulatory non-compliance

    Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.

    Product
    Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P
    Category
    Medical Device
    Distribution
    Distributed nationwide