Recall Z-1934-2026
Cook Incorporated · initiated April 2, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
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 16843258 16845235 16845236 16839886 16845242 16845244 16845223 16845223X 16845226 16846777 16845230 16845227 16833315 16845218 16845246 16845233 16846778 16845229 16845240 16846779 16845241 16855694 16851384 16855695 16852208 16855693 16855697 16852207 16851381 16861733 16852711 16855688 16849691…
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.
FDA-determined cause: Under Investigation by firm
Action taken
On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.
Details
- Recall number
- Z-1934-2026
- Initiated
- April 2, 2026
- Posted by FDA
- May 1, 2026
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 11,253
- Distribution
- 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
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1935-2026 Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |
| Z-1936-2026 Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |