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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4501–4525 of 27364

  • HighFDA (Devices)·Z-3017-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
    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-2993-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.

    Product
    Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3070-2024·2024-09-18

    Medline Sterile Medical Kit with Mislabeled Non-sterile Component Recalled

    Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.

    Product
    KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
    Category
    Medical Device
    Distribution
    3 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-3076-2024·2024-09-18

    Syringes with Luer Slip Tips Recalled for Unapproved Design Modifications

    Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.

    Product
    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 8403685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3013-2024·2024-09-18

    Medline CYSTO PACK Convenience Kits Recalled for Defective Syringes

    Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.

    Product
    Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3010-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER INSERTION KIT CLABSI , Pack Number CVI4880; 4) CHEST INSERTION PACK-LF , Pack Number DYNJ17634D ; 5) URETEROSCOPY, Pack Number D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3033-2024·2024-09-18

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

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

    Product
    Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack Nu
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3051-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Num
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3052-2024·2024-09-18

    Medline surgical convenience kits recalled due to defective plastic syringes

    Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3059-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects

    Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT ,
    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-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-2990-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, P
    Category
    Medical Device
    Distribution
    0 states
  • 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-3057-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling Convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality defects that may pose a risk to patient safety.

    Product
    Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3126-2024·2024-09-18

    Proton Beam Therapy System Displays Insufficient CBCT Images on Button Press

    Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam wit
    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
  • CriticalFDA (Devices)·Z-2943-2024·2024-09-11

    Trilogy Evo Ventilator Software Update for Identified Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.

    Product
    Trilogy Evo Universal Ventilator, Model No. DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2944-2024·2024-09-11

    Philips Respironics Trilogy Evo Ventilator Software Update Addresses Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.

    Product
    Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2942-2024·2024-09-11

    Trilogy Evo EV300 Ventilator Mandatory Software Update for Safety Issues

    Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.

    Product
    Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2721-2024·2024-09-11

    Fresenius Kabi IV Administration Sets Recalled for Uncontrolled Medication Flow Risk

    Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.

    Product
    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2690-2024·2024-09-11

    Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk

    Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.

    Product
    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2949-2024·2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    Product
    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
    Category
    Medical Device
    Distribution
    8 states