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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

BD Pyxis Automated Dispensing Devices Recalled for Labeling Update

Agency Publication Date: February 21, 2025
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Summary

CareFusion 303, Inc. is recalling 1,521 BD Pyxis MedFlex, MedBank Tower, and MedBank MedPass automated dispensing devices to update their user guides and safety manuals. This recall addresses the need for stronger instructions regarding manual access to medications during power outages or device malfunctions. No incidents or injuries have been reported in connection with this issue. These devices are used in hospitals and pharmacies to store and dispense critical medications.

Risk

If a device loses power or malfunctions, healthcare providers may experience delays in retrieving critical medications if they do not follow specific manual override procedures. Such delays could potentially lead to patient harm in emergency or time-sensitive clinical situations.

What You Should Do

  1. This recall affects BD Pyxis MedFlex (model 1119-00), MedBank Tower (model 1145-00), and MedBank MedPass (model 139088-01) automated dispensing devices, as well as their associated user guides and quick reference guides.
  2. Identify if your device is affected by checking the model (REF) and serial number on the device label, which is typically found on the back or side of the unit. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and its current documentation until you have received and reviewed the updated labeling provided by the manufacturer.
  4. Contact the manufacturer or your distributor to arrange for the necessary labeling updates, replacement user guides, or software corrections.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device and its documentation. Contact the manufacturer or your distributor to arrange for a labeling update, replacement of user guides, or corrective software actions.

Affected Products

Product: BD Pyxis MedFlex
Model / REF:
1119-00
Serial Numbers (461):
13517006
13523350
13754724
13767953
13789575
13801727
13826187
13879544
13883357
13884848
13934472
13939327
13948724
14032802
14037891
14158187
14159916
14168580
14172832
14175162
14182716
14202337
14220872
14222746
14228149
14228150
14244101
14254813
14254816
14254812
14254815
14275112
14278095
14317945
14317946
14324386
14332058
14347747
14347748
14349106
14348708
14348709
14352459
14365786
14365785
14374965
14374963
14374964
14377079
14378428
UDI:
10885403512704

Associated User Guides and QRGs include: BD Pyxis MedBank Cabinet User Guide v2.4, MedBank CR Station User Guide v3.10, myQLink Cloud Software User Guide v1.5, Supply Cabinet Safety Guide, and various Quick Reference Guides.

Product: BD Pyxis MedBank Tower
Model / REF:
1145-00
Serial Numbers (1051):
15383483
15389562
15422138
15422139
15442792
15500700
15500693
15504839
15504841
15518256
15518261
15550844
15550852
15550857
15569626
15598106
15600761
15639702
15654701
15654698
15662824
15662821
15684799
15684812
15715761
15715760
15715748
15715742
15723806
15723817
15728652
15728657
15747087
15761382
15770179
15770181
15770187
15770221
15770215
15770217
15770207
15770172
15806707
15806718
15867348
15928765
15930653
15932837
15935612
15941687
UDI:
10885403517167

Associated guides include BD Pyxis MedBank MedPass User Guide v1.0, MedBank CR Station QRG, and MedBank RxNow Solution QRG 2.0.

Product: BD Pyxis MedBank MedPass
Model / REF:
139088-01
Serial Numbers:
43847406
43847407
44684409
44684415
44684412
44688684
44694783
44740218
44775526

Includes MedBank MedPass User Guide v1.0 and MedBank MedPass QRG (PN 155022-03).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96150
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Authorized hospital and pharmacy distribution channels
Manufactured In: United States
Units Affected: 1521
Distributed To: Arizona, Florida, New Jersey, Kentucky, Georgia, California, Illinois, Maryland, Wisconsin, Ohio, North Carolina, Mississippi, New York, Missouri, Pennsylvania, Oregon, Indiana, Texas, Utah, Oklahoma, Michigan, Washington, Alabama, Nevada, Maine, West Virginia, Nebraska, District of Columbia, Massachusetts, Montana, Kansas, Colorado, Tennessee, Iowa, Minnesota, Arkansas, Idaho, South Carolina, South Dakota, Connecticut, Hawaii, Virginia, North Dakota, Alaska, New Mexico, Vermont, Louisiana, Wyoming

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 ยท 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.