Cook Incorporated medical device recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98682
- Recall initiated
- Apr 2, 2026
- Classified by FDA
- May 1, 2026
- Posted in Enforcement Report
- May 13, 2026
- Recalling firm
- Cook Incorporated
- Firm location
- Bloomington, IN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 2, 2026. FDA classified it 29 days later, on May 1, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay Cook Incorporated has 78 recalls in our records.
Recalled products (3)
Z-1934-2026 Class I Ongoing
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Codes / lots: UDI-DI 00827002119161 Lots 16905390 16905390X 16888263 NS16888264 16905391 16905391X 16909577 16918137 16924645 16924646 16928311 16928311X 16928312 16928313 16947353 16899656 16899655 16894976 16879299 16890985 16903201 16885859 16890986 16890982 16888268 16904428 16899658 16903202 16903203 16903204 16905389 16888267 16890983 16888269 16890981 16879296 16864346 16879301 16888261 16864344 16864351 16846774 16869144 16879300 16864350 16869143 16869143X NS16861721 16879297 16861735 16864347 16864347X 16882666 16899657 16890984 16899659 16888266 16861729 16857145 16858460 16857141 16861730 16861724 16858463 16852206 16855698 16858458 16858461 16858462 16858462X 16861726 16861727 16861728 16852209 16855686 16855696 16857146 16859718 16861720 16861723 16861725 16857137 16857142 16857139 16857140 16877835 16864345 16882665 16864353 16864348 16865462 16865462X 16879302 16843256 16833320…
Quantity: 11,253
Z-1935-2026 Class I Ongoing
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Codes / lots: UDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191
Quantity: 271
Z-1936-2026 Class I Ongoing
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
Codes / lots: G31213 UDI-DI 00827002312135 Lot 16805456 G31214 UDI-DI 00827002312142 Lots 16886459 16874181 16855513 16867505 16815763 16796665 16802282 16766437 16734169 16695772 G31216 UDI-DI 00827002312166 Lots 16886460 16891299 16912494 16831676 16836358 16836359 16836360 16864534 16864652 16881655 16882508 16912493 16872559 16878260 16824312 16831675 16874182 16855514 16868889 16859732 16858079 16878261 16806270 16804619 16805454 16804399 16815762 16803920 16803921 16802096 16802097 16814369 16814370 16806333 16804620 16831528 16822289 16822290 16782945 16782946 16795733 16796300 16779437 16795734 16800424 16802632 16824313 16764526 16763024 16800730 16802633 16802133 16800731 16821105 16824314 16711110 16717839 16730326 16720153 16736740 16739291 16693653 16690051 16673569 16680240 16704378 G31220 UDI-DI 00827002312203 Lots 16881657 16872241 16827163 16852999 16805455 16804400 16802132 16779438…
Quantity: 4,245
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98682
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.