139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8H

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Recall #: Z-1229-2025
Affected scope: N/A
Initiated: January 8, 2025

Compiled from official public sources by the publisher. · Updated September 2026

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CareFusion 303, Inc. recalled 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 13905… - a moderate-severity action.

139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 13905… was recalled by CareFusion 303, Inc. in March 5, 2025. Reason: Labeling update to include a contraindication statement against the use of medicine cabinets in procedure an…. Check the official notice for the remedy. Verify recall #Z-1229-2025 with the FDA Devices before acting.

The recall

CareFusion 303, Inc. issued this moderate-severity FDA Devices recall-Labeling update to include a contraindication statement against the use of medicine cabinets in procedure an….

Moderate
severity level: Class II
classification: March 5, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1229-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX

Reason for recall

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1229-2025
Date reported	March 5, 2025
Date initiated	January 8, 2025
Recalling firm	CareFusion 303, Inc.
Firm location	San Diego, CA
Affected scope	N/A
Distribution	US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI,…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1229-2025) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1229-2025.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported March 5, 2025. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026