SwabCap and SwabSleeve Disinfecting Caps Recalled for Disinfection Risk

Agency Publication Date: July 11, 2025

Summary

ICU Medical, Inc. is recalling 1,445,600 SwabCap and SwabSleeve Disinfecting Caps because a manufacturing defect may cause the foil seal on the container to be incomplete. This issue allows the isopropyl alcohol on the cleaning sponge to evaporate, leaving the sponge dry. Without the alcohol, the device cannot properly disinfect needle-free connectors, which may lead to infections in patients requiring intravenous (IV) treatment.

Risk

If the alcohol in the disinfecting cap evaporates, the device fails to properly sanitize medical connectors. This can introduce bacteria into a patient's bloodstream or IV line, potentially causing serious infections or medical complications.

What You Should Do

This recall affects SwabCap and SwabSleeve Disinfecting Caps for needle-free connectors, specifically those sold in 200-count boxes (REF SCXT3-2000) and SwabSleeve variants (REF SCXT3-5-2000).
Identify if your product is affected by checking the REF number, lot number, and expiration date printed on the product packaging or box label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled disinfecting caps immediately.
Contact ICU Medical, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
For further information or to report concerns, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SwabSleeve Disinfecting Cap for Needlefree Connectors

Model / REF:

SCXT3-5-2000

Lot Numbers:

14258739 (Exp 1-Dec-26)

14258743 (Exp 1-Feb-26)

14258744 (Exp 1-Dec-26)

14264200 (Exp 1-Dec-26)

14272241 (Exp 1-Dec-26)

14272248 (Exp 1-Dec-26)

14287456 (Exp 1-Dec-26)

14287459 (Exp 1-Dec-26)

14287480 (Exp 1-Dec-26)

14287482 (Exp 1-Dec-26)

14287485 (Exp 1-Dec-26)

14294832 (Exp 1-Dec-26)

14272254 (Exp 1-Dec-26)

14310313 (Exp 1-Dec-26)

14310425 (Exp 1-Dec-26)

14323354 (Exp 1-Dec-26)

14287475 (Exp 1-Dec-26)

14294840 (Exp 1-Dec-26)

14321645 (Exp 1-Jan-27)

14321652 (Exp 1-Jan-27)

14331169 (Exp 1-Jan-27)

14332773 (Exp 1-Jan-27)

14341732 (Exp 1-Oct-26)

14294825 (Exp 1-Jan-27)

14303209 (Exp 1-Jan-27)

14310308 (Exp 1-Jan-27)

14355404 (Exp 1-Jan-27)

14355409 (Exp 1-Jan-27)

UDI:

10887709097107

Firm initiated voluntary recall.

Product: SwabCap Disinfecting Cap for Needlefree Connectors (200-ct. Box)

Variants: 200-count Box

Model / REF:

SCXT3-2000

Lot Numbers:

14258214 (Exp 1-Jan-27)

14258206 (Exp 1-Jan-27)

14258208 (Exp 1-Feb-27)

UDI:

20887709079162

Firm initiated voluntary recall.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96903

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: Medical Supply Distributors; Healthcare Facilities; Authorized Dealers

Manufactured In: United States

Units Affected: 1,445,600

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects SwabCap and SwabSleeve Disinfecting Caps for needle-free connectors, specifically those sold in 200-count boxes (REF SCXT3-2000) and SwabSleeve variants (REF SCXT3-5-2000).

Identify if your product is affected by checking the REF number, lot number, and expiration date printed on the product packaging or box label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled disinfecting caps immediately.

Contact ICU Medical, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected units.

For further information or to report concerns, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Affected Products

Product: SwabSleeve Disinfecting Cap for Needlefree Connectors

Model / REF:

SCXT3-5-2000

Lot Numbers:

14258739 (Exp 1-Dec-26)

14258743 (Exp 1-Feb-26)

14258744 (Exp 1-Dec-26)

14264200 (Exp 1-Dec-26)

14272241 (Exp 1-Dec-26)

14272248 (Exp 1-Dec-26)

14287456 (Exp 1-Dec-26)

14287459 (Exp 1-Dec-26)

14287480 (Exp 1-Dec-26)

14287482 (Exp 1-Dec-26)

14287485 (Exp 1-Dec-26)

14294832 (Exp 1-Dec-26)

14272254 (Exp 1-Dec-26)

14310313 (Exp 1-Dec-26)

14310425 (Exp 1-Dec-26)

14323354 (Exp 1-Dec-26)

14287475 (Exp 1-Dec-26)

14294840 (Exp 1-Dec-26)

14321645 (Exp 1-Jan-27)

14321652 (Exp 1-Jan-27)

14331169 (Exp 1-Jan-27)

14332773 (Exp 1-Jan-27)

14341732 (Exp 1-Oct-26)

14294825 (Exp 1-Jan-27)

14303209 (Exp 1-Jan-27)

14310308 (Exp 1-Jan-27)

14355404 (Exp 1-Jan-27)

14355409 (Exp 1-Jan-27)

UDI:

10887709097107

Firm initiated voluntary recall.

Product: SwabCap Disinfecting Cap for Needlefree Connectors (200-ct. Box)

Variants: 200-count Box

Model / REF:

SCXT3-2000

Lot Numbers:

14258214 (Exp 1-Jan-27)

14258206 (Exp 1-Jan-27)

14258208 (Exp 1-Feb-27)

UDI:

20887709079162

Firm initiated voluntary recall.