Class II U.S. Food and Drug Administration

Medline recall: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific

Recall published last month

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3070-2026
Published
September 9, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
222,653 total
Distribution
Nationwide
Made in
United States
Lot / code info
DYNDV1875 UDI-DI 10888277860209 Lot 24JMB689 ACC010972 UDI-DI 10198459303289 Lots 25DDA151 25DDA401 25EDA655 ACC010479A UDI-DI 10195327131517 Lot 25BDB620 ACC010690 UDI-DI 10195327433307 Lots 24LDB023 25BDA230 25GDA245 25JDB903 25KDB182 25LDA088 25LDA809 26ADC073 26CDA991 26DDB182 26EDA950 26EDB485 26FDB456 ACC010875 UDI-DI 10198459113659 Lots 24JDA648 25CDB776 25JDB205 25KDB028 25LDB271 26DDA182 26DDA786 26EDA629 ACC011073 UDI-DI 10198459569333 Lot 25LDA072 ACC011088 UDI-DI 10198459589577 Lots 26BDA548 26GDA090 ACC011067 UDI-DI 10198459529184 Lots 25KDA639 25LDA980 26CDB158 DYKM1564 UDI-DI 10889942754571 Lots 24HBW937 24JBX634 24LBR085 25GBH209 25IBK590 25LBD525 26ABI524 26BBM585 26DBC555 DYKM1564A UDI-DI 10198459805165 Lot 26FBK649 DYNJT10325 UDI-DI 10198459787324 Lots 26EBM250 26FBA470 26FBF055 26FBH553 26FBH554 DYKS1089B UDI-DI 10193489306286 Lots 24JMG846 24LMD918 25GMD759 25GMK431 25IMF050 25KMJ026 26BMC073 26DMI048 DYNJ63410 UDI-DI 10193489737431 Lots 24LDB851 25BDA890 DYNDH1363 UDI-DI 10888277795464 Lots 24IBH349 24IBS200 24JBQ160 24KBN447 24LBG380 24LBI547 25ABW563 25DBH954 25GBD824 25HBT172 25IBO192 25JBB921 25JBQ987 ACC010770 UDI-DI 10195327576998 Lots 25HDA878 25IDA087 25IDA817 25JDB317 25KDB340 25LDB061 26ADA012 26ADA159 26ADB380 26ADC072 26BDA633 26CDA678 DYNDH1591 UDI-DI 10193489497236 Lots 24JMA966 25GMD752 25LMJ154 26AME497 26BMA252 26DMI088 26EMH914 26FMH453 26FMK588 EDUC1043 UDI-DI 10195327425531 Lots 24KDA258 24KDA880 24KDA963 EDUC1043A UDI-DI 10198459334559 Lots 25FLA817 25GLA090 25KLA077 25KLA693 26CLB165 26CLB165Z 26ELA472 DYKM1496 UDI-DI 10889942636082 Lot 24KBL243 DYNDV2520 UDI-DI 10653160384045 Lot 2024111990
UPC codes
10888277860209, 10198459303289, 10195327131517, 10195327433307, 10198459113659, 10198459569333, 10198459589577, 10198459529184, 10889942754571, 10198459805165, 10198459787324, 10193489306286, 10193489737431, 10888277795464, 10195327576998, 10193489497236, 10195327425531, 10198459334559, 10889942636082, 10653160384045

Products covered by this recall

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520

Check your product

The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10888277860209
  • 10198459303289
  • 10195327131517
  • 10195327433307
  • 10198459113659
  • 10198459569333
  • 10198459589577
  • 10198459529184
  • 10889942754571
  • 10198459805165
  • 10198459787324
  • 10193489306286
  • 10193489737431
  • 10888277795464
  • 10195327576998
  • 10193489497236
  • 10195327425531
  • 10198459334559
  • 10889942636082
  • 10653160384045

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 653 total

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 mL

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10888277860209, 10198459303289, 10195327131517; lot code 653 total. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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