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RecallWatchMedical Device Safety
Class IOngoingZ-1934-2026

Cook Incorporated recalls Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters f…

Cook IncorporatedBloomington, IN, United StatesReported May 13, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 experienceUDI
    UDI-DI 00827002119161
    400 affected lots
    1690539016905390X16888263NS168882641690539116905391X1690957716918137
    +392 more16924645169246461692831116928311X1692831216928313169473531689965616899655168949761687929916890985169032011688585916890986168909821688826816904428168996581690320216903203169032041690538916888267168909831688826916890981168792961686434616879301168882611686434416864351168467741686914416879300168643501686914316869143XNS1686172116879297168617351686434716864347X168826661689965716890984168996591688826616861729168571451685846016857141168617301686172416858463168522061685569816858458168584611685846216858462X16861726168617271686172816852209168556861685569616857146168597181686172016861723168617251685713716857142168571391685714016877835168643451688266516864353168643481686546216865462X1687930216843256168333201684325816845235168452361683988616845242168452441684522316845223X16845226168467771684523016845227168333151684521816845246168452331684677816845229168452401684677916845241168556941685138416855695168522081685569316855697168522071685138116861733168527111685568816849691NS16845220NS16845220X1684677116846776168452311685137916851378168513741684677516851376168556901684968816846770168467731686173116861731X168617321686435216864354NS1686172216857144168556911685569216846772168513801686173416861734X16864349168513821685714316857143X168332281683329816833292168333211684523916836838168398871682305516807168168168081682304516833290168332991683683916836839X1683331616833314168333101682306216823062X168254841683322916833230168332311683323216833289168333071683330816833309168333111683331216833313168332961684523716802095168333011683330216843254168432551684325716845234168332971683329316833304168333001680209116802091X168332911683330316800397168003991680209216823046168230471682304816823049168230501682305116823052168230531682305416823059168230601682306116825481168300731682306416825482168230561682548316802093168333061680209416800398168333051682306316833226168332271684192216845228168452381684968616849687NS168452211683331916833318168496891684969016849692168496931685137516851377168333171684522416845222168452431684524516845225168452191684523216855689168513831685138516855687168230581682305716830072168332951683329416785145168003931678515416800392167851561676333116763325NS167606641677906516763326167851471678190916785146167851481678514916785150167851551680039516800395X1680039616800396X167958251677888016778880X1677887916778886167788821676807516778874167788751677887616778877167788781677906616779067167790731678071216780713167559011676333216760667167680781676332916763330167131931672602916727639167260311672047716721538167311071673110816731109167311101673493016734931NS16731105NS167311061672603416721055167527351671840916734933167167431675273216748454167484551673493916720476167790631677888416779064167788851677906816716747167167421671674516781899167836211678514216778873NS167606631674251016742505167819011678190016781906167819021676333416763327167425121674251116742511X1675871516755900167606651675871616758713167788811675871216758717167559051675871816763328168003901678998916789989X1678999216789992X1678999116789993167958221679582316797411167680771676807616779062167680741677888316779069167790721678071716779071167807141678190816781907167836151678071916780718167819031679741216800394

What the firm is doing

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.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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