FDA Medical Device Recalls (openFDA)

Smiths Medical ASD Inc.: smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

Recall number: Z-3087-2024
Recalling firm: Smiths Medical ASD Inc.
Product: smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090
Status: Open, Classified
Initiated: 2024-06-07
Posted: 2024-09-11
Terminated: not on file
Reason: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
Root cause: Process control
Action: Smiths Medical issued an URGENT MEDICAL DEVCIE NOTIFICATION to its consignees on 06/07/2024 via traceable mailing. The notice explained the issue with the device, potential risk to the patient, and requested the affected devices be discarded. Distributor were directed to forward the notice to their customers. For questions: Customer service: customerservice@icumed.com; 800-258-5361) Complaints: globalcomplaints@icumed.com; 866-216-8806
Quantity: 12234 units
Distribution: Worldwide
Lot, serial or model codes: 101/540/080, Lot Number 3943992; 101/540/080, Lot Number 4258998; 101/540/090, Lot Number 4309778; 101/541/070, Lot Number 3887542; 101/541/070, Lot Number 3913366; 101/541/070, Lot Number 4202486; 101/541/070, Lot Number 4350937; 101/541/080, Lot Number 3887517; 101/541/080, Lot Number 3910324; 101/541/080, Lot Number 3912758; 101/541/080, Lot Number 4170885; 101/541/080, Lot Number 4184037; 101/541/080, Lot Number 4310310; 101/541/080, Lot Number 4312324; 101/541/080, Lot Number 4332049; 101/541/080, Lot Number 4332050; 101/541/090, Lot Number 3887526; 101/541/090, Lot Number 3925818; 101/541/090, Lot Number 4234865; 101/541/090, Lot Number 4266477; 101/541/090, Lot Number 4310313; 101/543/070, Lot Number 3887541; 101/543/070, Lot Number 4310304; 101/543/080, Lot Number 3887527; 101/543/080, Lot Number 3910325; 101/543/080, Lot Number 4310447; 101/543/080, Lot Number 4332051; 101/543/080, Lot Number 4332052; 101/543/080, Lot Number 4332053; 101/543/080, Lot Number 4332054; 101/543/080, Lot Number 4382017; 101/543/080, Lot Number 4382018; 101/543/080, Lot Number 4382019; 101/543/080, Lot Number 4382020; 101/543/080, Lot Number 4382021; 101/543/080, Lot Number 4382022; 101/543/080, Lot Number 4382023; 101/543/080, Lot Number 4382024; 101/543/080, Lot Number 4382025; 101/543/090, Lot Number 3887518; 101/543/090, Lot Number 4384983; 101/891/070, Lot Number 3910414; 101/891/070, Lot Number 3925816; 101/891/070, Lot Number 4117953; 101/891/070, Lot Number 4156869; 101/891/070, Lot Number 4205521; 101/891/070, Lot Number 4232678; 101/891/080, Lot Number 3887523; 101/891/080, Lot Number 3896997; 101/891/080, Lot Number 3896998; 101/891/080, Lot Number 4306752; 101/891/080, Lot Number 4388711; 101/891/090, Lot Number 3913655; 101/891/090, Lot Number 3925770; 101/891/090, Lot Number 4005342; 101/891/090, Lot Number 4310412; 101/892/070, Lot Number 3950087; 101/892/080, Lot Number 3943993; 101/892/080, Lot Number 4165114; 101/892/080, Lot Number 4226926; 101/892/090, Lot Number 3944020; 101/892/090, Lot Number 4194294; 101/893/070, Lot Number 3925807; 101/893/070, Lot Number 4005284; 101/893/070, Lot Number 4005285; 101/893/070, Lot Number 4089723; 101/893/070, Lot Number 4117954; 101/893/070, Lot Number 4138223; 101/893/070, Lot Number 4189353; 101/893/070, Lot Number 4270948; 101/893/070, Lot Number 4281033; 101/893/080, Lot Number 3910326; 101/893/080, Lot Number 3912757; 101/893/080, Lot Number 4005351; 101/893/080, Lot Number 4010052; 101/893/080, Lot Number 4070524; 101/893/080, Lot Number 4165747; 101/893/080, Lot Number 4205522; 101/893/080, Lot Number 4238251; 101/893/080, Lot Number 4281154; 101/893/080, Lot Number 4281202; 101/893/080, Lot Number 4285878; 101/893/080, Lot Number 4289001; 101/893/080, Lot Number 4310416; 101/893/080, Lot Number 4310417; 101/893/080, Lot Number 4310418; 101/893/080, Lot Number 4310419; 101/893/080, Lot Number 4343143; 101/893/080, Lot Number 4382056; 101/893/080, Lot Number 4382057; 101/893/080, Lot Number 4382058; 101/893/080, Lot Number 4382059; 101/893/080, Lot Number 4382060; 101/893/080, Lot Number 4382061; 101/893/090, Lot Number 3925810; 101/893/090, Lot Number 4177907; 101/893/090, Lot Number 4310430; 101/893/090, Lot Number 4310431; 101/893/090, Lot Number 4310432; 101/893/090, Lot Number 4310433; 101/893/090, Lot Number 4310434; 101/893/090, Lot Number 4310435
510(k) numbers: ["K173384"]
PMA numbers: not on file
Product code: BTO
Firm FEI: 3012307300
Firm city: Minneapolis
Firm state: MN
Firm country: not on file

Where this comes from

Register: FDA Medical Device Recalls (openFDA)
Publisher: U.S. Food and Drug Administration (openFDA)
File: device-recall-0001-of-0001.json.zip
sha256: b87518bfe2e8
Size: 288210821 bytes
Published: 2026-09-28
Read: 2026-09-29T08:25:23.626Z
Source file: Source file retained · verify
Refresh due: 2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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