The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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5976–6000 of 39968

  • HighFDA (Devices)·Z-3075-2024·2024-09-18

    SOL-CARE and SOL-M syringes recalled for unapproved design modifications

    Sol-Millennium Medical Inc. is recalling SOL-CARE and SOL-M syringes with safety needles because the devices are substantially different from FDA-cleared versions, with major modifications to intended use.

    Product
    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3042-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3015-2024·2024-09-18

    Medline medical convenience kits with syringes recalled due to leakage and breakage

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack Numb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3001-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and other quality defects that may pose a risk to patient health. Kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747A ; 4) NC3G MEDIASTINOSCOPY PACK-LF, Pack Number DYNJ0796243D ; 5) MEDIASTIN
    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-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-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-2999-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.

    Product
    Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack Number
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3023-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Convenience kits with plastic syringes affected by an FDA safety alert are being recalled due to leaks, breakage, and quality issues that may harm patients.

    Product
    Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) L
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3061-2024·2024-09-18

    Medline Burn Packs Recalled Due to Syringe Quality Issues

    Medline is recalling burn convenience kits because they contain plastic syringes with leaks or breakage risks identified in an FDA Safety Alert.

    Product
    Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3101-2024·2024-09-18

    Siemens Atellica IM CA 19-9 Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 kits due to positive bias in some samples, particularly in the Asia Pacific population.

    Product
    Atellica IM CA 19-9 (250 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:10995489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3018-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3123-2024·2024-09-18

    BioFire FILMARRAY TORCH Module Recall Due to Calibration Errors

    BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.

    Product
    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3028-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects

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

    Product
    Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY , Pac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3016-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3124-2024·2024-09-18

    Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines

    Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.

    Product
    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2991-2024·2024-09-18

    Medline Cardiac Pacing Kits Recalled for Syringe Quality Issues

    Medline is recalling cardiac pacing kits containing plastic syringes with leaks or breakage risks. The recall addresses quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3005-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

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

    Product
    Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F ; 2) URETEROSCOPY TRAY-RF, Pack Number DYNJ27442U ; 3) URETHROPLASTY PACK, Pack Number DYNJ39700B ; 4) RRP PACK, Pack Number DYNJ44109B ; 5) PROSTATECTOMY PACK-LF , Pack Number DYNJ6
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2992-2024·2024-09-18

    Medline Medical Convenience Kits with Defective Syringes Recalled

    Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.

    Product
    Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3092-2024·2024-09-18

    Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect

    Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-3007-2024·2024-09-18

    Medline Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3093-2024·2024-09-18

    Medline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal

    Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3036-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3109-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide