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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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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Cook Beacon Tip Angiographic Catheters Recalled for Potential Tip Separation

Agency Publication Date: June 16, 2025
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Summary

Cook Incorporated has recalled 26,986 Beacon Tip 5.0 Fr Angiographic catheters due to identifying that affected device lots may experience tip separation. These catheters are used in medical procedures to assist in diagnosing and treating conditions in blood vessels. The recall covers various configurations, including different shaft lengths, tip shapes, and catheters with specialized hydrophilic coatings. While no injuries have been reported in this notice, tip separation is a critical defect that can lead to serious patient harm. Medical facilities should stop using the affected lots immediately and contact the manufacturer or their supplier.

Risk

The catheter tip may separate or detach from the device during use inside a patient's body. If this occurs, it can cause the fragment to block blood vessels, damage the vessel walls, or require further medical intervention or emergency surgery to retrieve the detached piece.

What You Should Do

  1. This recall affects Beacon Tip 5.0 Fr Angiographic catheters sold in numerous configurations, which can be identified by the Reference Product Number (RPN) and Lot Number printed on the product labeling.
  2. Check your medical inventory for recalled RPNs including HNBR5.0-35-100-P-NS-C2, HNBR5.0-35-40-P-NS-KMP, HNBR5.0-38-65-P-NS-KMP, and many others. See the Affected Products section below for the full list of affected codes.
  3. Identify affected units by checking for lot numbers such as 15881668, 15993143, 16039989, and NS15912380. See the Affected Products section below for the full list of affected lot numbers.
  4. Stop using the recalled device immediately to avoid potential complications from tip separation.
  5. Contact Cook Incorporated or your medical supply distributor to arrange for the return, replacement, or correction of any affected catheters in your possession.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall or have experienced an adverse event.

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: Beacon Tip 5.0 Fr Angiographic Cathetersby Cook Medical
Variants: Various shaft lengths, Various tip curves, Some with hydrophilic coating
Model / REF (132):
HNBR5.0-35-100-P-NS-C2
G08796
HNBR5.0-35-100-P-NS-DAV
G08699
HNBR5.0-35-100-P-NS-H1
G08421
HNBR5.0-35-100-P-NS-JB2
G08809
HNBR5.0-35-100-P-NS-SIM1
G08471
HNBR5.0-35-100-P-NS-SIM2
G08422
HNBR5.0-35-100-P-NS-SIM3
G08597
HNBR5.0-35-100-P-NS-VERT
G11483
HNBR5.0-35-125-P-NS-C2
G12899
HNBR5.0-35-125-P-NS-VANSCHIE1
G35733
HNBR5.0-35-125-P-NS-VANSCHIE4
G35736
HNBR5.0-35-125-P-NS-VANSCHIE5
G35737
HNBR5.0-35-40-P-NS-KMP
G09751
HNBR5.0-35-40-P-NS-VANSCHIE3
G31408
HNBR5.0-35-65-P-NS-C1
G08441
HNBR5.0-35-65-P-NS-C2
G08442
HNBR5.0-35-65-P-NS-C3
G08443
HNBR5.0-35-65-P-NS-KMP
G11458
HNBR5.0-35-65-P-NS-RBT
G57015
HNBR5.0-35-65-P-NS-RC1
G08469
HNBR5.0-35-65-P-NS-RC2
G08470
HNBR5.0-35-65-P-NS-RDC
G08596
HNBR5.0-35-65-P-NS-RIM
G08444
HNBR5.0-35-65-P-NS-VANSCHIE1
G13795
HNBR5.0-35-65-P-NS-VANSCHIE2
G13794
Lot Numbers (194):
15881668
15903001
NS15932463
16003554
15948423
15953578
15984088
15907359
15879285
NS15912380
NS15995667
15972583
15937655
15972584
15995781
15995782
15881670
15895236
15948424
15957900
15976870
15979535
15980166
15993143
16008638
15950809
15972586
15895237
15912387
15972587
15976871
15979536
15980167
15993144
16003545
15978551
15940019
15957901
15993139
16003556
15921475
15942327
15972578
15972577
16017882
16005235
15932470
15932471
15984090
15993140
UDI (132):
00827002087965
10827002087962
00827002086999
10827002086996
00827002084216
10827002084213
00827002088092
10827002088099
00827002084711
10827002084718
00827002084223
10827002084220
00827002085978
10827002085975
00827002114838
10827002114835
00827002128996
10827002128993
00827002357334
10827002357331
00827002357365
10827002357362
00827002357372
10827002357379
00827002097513
10827002097510
00827002314085
10827002314082
00827002084414
10827002084411
00827002084421
10827002084428
00827002084438
10827002084435
00827002114586
10827002114583
00827002570153
10827002570150
00827002084698
10827002084695
00827002084704
10827002084701
00827002085961
10827002085968
00827002084445
10827002084442
00827002137950
10827002137957
00827002137943
10827002137940

Quantity: 26986 units. Reference Product Numbers (RPN) and Global Product Numbers (GPN) used to identify specific catalog configurations.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96848
Status: Active
Manufacturer: Cook Incorporated
Sold By: hospitals; medical supply distributors
Manufactured In: United States
Units Affected: 26986 units
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 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.