The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1932-2026·Announced 2026-04-29

IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled

LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall involving sterility failure in a device used in invasive medical procedures. Non-sterile materials in IV start kits create a significant risk of infection and potential hospitalization, meeting the criteria for Severe classification.

Plain-English summary

LSL Healthcare Inc. is recalling its IV Start Kit, Model/Catalog Number 3131, due to the presence of Webcol Large Alcohol Prep Pads that do not meet sterility requirements. Approximately 2,200 units were distributed nationwide in the states of Maryland, Illinois, and Minnesota.

The non-sterile alcohol prep pads pose a risk of infection when used in medical procedures that require sterile conditions. Non-sterile materials used in IV insertion procedures could compromise patient safety.

Consumers and healthcare facilities should cease use of affected kits immediately. The recalled product can be identified by Lot Code Model No. 3131, UDI-DI 00661392054271, Lot #6A3139, with expiration date 01/21/2028, and GTIN (01)00661392054271(10)6A3139(17)280121. Healthcare providers should contact LSL Healthcare Inc. for instructions on returning or disposing of affected units.

The recalled product

Product
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Affected units
2,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot Code: Model No. 3131
  • UDI-DI 00661392054271
  • Lot#6A3139
  • Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 6 recalled by LSL Healthcare Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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