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Use caution Medical device recall · FDA · Published May 23, 2025

Medline Convenience Kits with BD Insyte Autoguard Catheters May Cause Slow Needle

Medline recalls convenience kits containing specific BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN that may cause slow or failed needle retraction during insertion. Affected kits have unique lot numbers and labels.

🇺🇸 FDA recall #Z-2043-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medline is recalling convenience kits that include BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. These catheters may slow or fail to retract during insertion, potentially causing injury. The recall affects specific kits with labeled lot numbers. Read more at govinfonow.com/recall/52221-medline-convenience-kits-with-bd-insyte-autoguard-catheters-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/52221-medline-convenience-kits-with-bd-insyte-autoguard-catheters-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2043-2025

Cite this page

“Medline Convenience Kits with BD Insyte Autoguard Catheters May Cause Slow Needle.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52221-medline-convenience-kits-with-bd-insyte-autoguard-catheters-may-cause. Based on FDA recall #Z-2043-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2043-2025%22&limit=1).

Why it’s dangerous

During IV catheter insertion, the needle may slow to retract or fail to retract. This can lead to complications such as improper catheter placement or injury to the patient. The issue is specific to certain catheter models and kits.

Who’s affected

Healthcare professionals using Medline convenience kits with specific BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN are most at risk. The recall applies to kits sold with the listed lot numbers and labels.

How to tell if you have this one

Check for kits labeled with specific reference numbers: CC DRAWER 4 IV CIRCULATION (REF ACC010254B), CC ADULT DRAWER 2 (REF ACC010256), PEDI EMERGENCY TRAY-BLUE (REF ACC010316A), ADULT DRAWER 4 (REF ACC010389C), DRAWER 4 - SUMMIT (REF ACC010627), or DRAWER 3 (REF ACC010898). Each kit has a unique lot number starting with 24LDA or 24LDB.

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
Recall numberProduct, codes & lotsQuantity
Z-2043-2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.; 1) REF ACC010254B: UDI/DI 10193489651683 (each), 40193489651684 (case), Lot Number: 24LDA269; 2) REF ACC010256: UDI/DI 10884389559529 (each), 40884389559520 (case), Lot Number: 24LDA106; 3) REF ACC010316A: UDI/DI 10889942831746 (each), 40889942831747 (case), Lot Number: 24LDA823; 4) REF ACC010389C: UDI/DI 10193489472493 (each), 40193489472494 (case), Lot Number: 24LDB092; 5) REF ACC010627: UDI/DI 10195327226589 (each), 40195327226580 (case), Lot Number: 24LDA268; 6) REF ACC010898: UDI/DI 10198459192074 (each), 40198459192075 (case), Lot Number: 24LDA260.186 units
Z-2044-2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665; 1) REF ACC010665: UDI/DI 10195327334918 (each), 40195327334919 (case), Lot Number 24LDA59036 units
Z-2045-2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B; 1) REF DYNJ0151148B: UDI/DI 10889942050819 (each), 40889942050810 (case), Lot Number 24LDA98080 units
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Labels

    Look for specific reference numbers and lot numbers on the kit packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Indiana, Kentucky, Michigan, Texas, Washington.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: May 23, 202512. FDA classified it Class II: Jun 30, 202523. Published in FDA’s Enforcement Report: Jul 9, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2043-2025 (May 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2043-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA