Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

Critical RiskFDA Device
Medical Devices

BD PowerPICC Catheters Recalled for Tubing Leaks and Health Risks

Agency Publication Date: April 16, 2025
Share:
Sign in to monitor this recall

Summary

Bard Access Systems, Inc. is recalling approximately 718,461 BD PowerPICC Catheters because the tubing can develop leaks due to material fatigue. The catheters were manufactured with tubing that exceeded technical specifications for melt flow, which can cause the material to crack or break during use. No injuries have been reported to date, but the defect can lead to life-threatening complications or the interruption of vital medical treatments. These devices are primarily used in hospitals and clinics for vascular access.

Risk

The tubing in these catheters may crack or leak prematurely, potentially allowing air bubbles to enter the bloodstream (air embolism) or causing medical fluids to leak into surrounding body tissues (extravasation). These failures pose serious risks of severe infection, internal bleeding, and foreign body embolisms where fragments of the device enter the circulatory system.

What You Should Do

  1. This recall affects BD 4 Fr Single-Lumen PowerPICC Catheters identified by specific catalog numbers (REF) and lot codes.
  2. Stop using the recalled devices immediately.
  3. Check the catalog number and lot number printed on the device packaging or label to determine if your inventory is affected.
  4. See the Affected Products section below for the full list of affected codes.
  5. Contact Bard Access Systems, Inc. or your medical distributor to arrange for the return, replacement, or correction of any recalled products.
  6. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD 4 Fr Single-Lumen PowerPICC Catheters
Model / REF (106):
3174155
CK000540
3174118
CK000483
3174335
3174355
CK000196
9174118
CK000955
3174135
CK000617
CK000839
3194355
6174118
3194135
3194335
2174108
9194118
3194118
1174118
CK000285C
CK000335A
CK000796
1194108D
CK000757
CK001042
9174108
1174108D1
CK000631B
3194155
3174108
CK000567
1194108D4
1174108D2
CK000677
CK000864
CK000937A
CK000930
CK001027
1174108D
CK000867
CK000900
CK000315A
CK000589A
CK000854B
CK000897
CK000953A
CK000586B
CK000549
CK000844
Lot Numbers (434):
REGQ0844(6/30/2025)
REGZ1439(11/30/2025)
REHP0860(11/30/2025)
REHQ3097(6/30/2026)
REHR0022(6/30/2026)
REHT1151(7/31/2026)
REHU1525(11/30/2026)
REHU2455(6/30/2026)
REHU2614(11/30/2026)
REHV2765(7/31/2026)
REJN3472(2/28/2027)
REJP4216(5/31/2027)
REJQ2272(7/31/2027)
REJR1411(8/31/2027)
REJR2565(4/30/2027)
REJR2614(8/31/2027)
REJT0755(9/30/2027)
REGZ1425(10/31/2025)
REHP0808(11/30/2025)
REHU1513(1/31/2026)
REHV2221(1/31/2026)
REHY2842(10/31/2026)
REJN4145(12/31/2026)
REJR1322(3/31/2027)
REJS2110(4/30/2027)
REJS3773(2/28/2027)
REGZ2512(11/30/2025)
REHP1760(1/31/2026)
REHP2603(1/31/2026)
REJN1059(12/31/2026)
REHN3187(10/31/2025)
REHQ1804(6/30/2026)
REJN1065(5/31/2027)
REJP2018(6/30/2027)
REJR1321(8/31/2027)
REHN3908(10/31/2025)
REHP0800(10/31/2025)
REHQ3070(11/30/2025)
REHT1129(5/31/2026)
REHU1519(6/30/2026)
REHV1391(7/31/2026)
REHV3050(7/31/2026)
REHZ1011(11/30/2026)
REJN4109(12/31/2026)
REJQ0405(2/28/2027)
REJR2090(3/31/2027)
REJT0833(5/31/2027)
REHQ1781(11/30/2025)
REHS1925(4/30/2026)
REHT1120(5/31/2026)
UDI (106):
00801741027611
00801741105142
00801741027598
00801741099397
00801741027628
00801741027635
00801741028847
00801741035562
00801741200922
00801741027604
00801741122286
00801741154393
00801741027789
00801741139017
00801741027758
00801741027772
00801741138966
00801741028618
00801741027741
00801741034466
00801741161117
00801741101281
00801741144783
00801741034510
00801741141133
00801741224324
00801741035548
00801741154737
00801741143748
00801741027765
00801741027574
00801741108167
00801741155093
00801741154836
00801741131790
00801741163302
00801741224003
00801741188091
00801741223921
00801741034459
00801741163272
00801741184956
00801741182723
00801741137624
00801741225802
00801741184925
00801741223303
00801741212789
00801741107313
00801741154690

Units were recalled because tubing exceeded melt flow index specifications, which could lead to increased material fatigue leaks.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96426
Status: Active
Manufacturer: Bard Access Systems, Inc.
Sold By: Authorized medical distributors; Direct hospital sales
Manufactured In: United States
Units Affected: 718,461
Distributed To: Nationwide
Agency Last Updated: May 16, 2025

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.