FDA Device recall Z-3087-2024

smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs P…

FDA Device
Class I
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class I recall of smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs P… by Smiths Medical Asd, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3087-2024
Classification	Class I
Status	ongoing
Initiated	2024-06-07
Published	2024-09-18
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	n/a

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

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.

Identifiers

code_info	101/540/080, Lot Number 3943992; 101/540/080, Lot Number 4258998; 101/540/090, Lot Number 4309778; 101/541/070, Lot… 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, L

code_info

101/540/080, Lot Number 3943992; 101/540/080, Lot Number 4258998; 101/540/090, Lot Number 4309778; 101/541/070, Lot…

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, L

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3087-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.