smiths medical portex BLUgriggs Percutaneous Dilation Procedural… — Class I medical device recall Z-3087-2024

Ongoing recall by Smiths Medical ASD Inc., reported 2024-09-18. There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within sp

Recall number	`Z-3087-2024`
Product type	Medical device
Classification	Class I
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Smiths Medical ASD Inc., Minneapolis, MN, United States
Recall initiated	2024-06-07
Classified	2024-09-11
Reported by FDA	2024-09-18
Quantity	12,234 units
Lot numbers	`101/540/080`, `101/540/090`, `101/541/070`, `101/541/080`, `101/541/090`, `101/543/070`, `101/543/080`, `101/543/090`, `101/891/070`, `101/891/080`, `101/891/090`, `101/892/070`, `101/892/080`, `101/892/090`, `101/893/070`, `101/893/080`, `101/893/090`, `3887517`, `3887518`, `3887523`, `3887526`, `3887527`, `3887541`, `3887542`, `3896997`, `3896998`, `3910324`, `3910325`, `3910326`, `3910414`, `3912757`, `3912758`, `3913366`, `3913655`, `3925770`, `3925807`, `3925810`, `3925816`, `3925818`, `3943992` and 79 more
Model numbers	`101/540/080`, `101/540/090`, `101/541/070`, `101/541/080`, `101/541/090`, `101/543/070`, `101/543/080`, `101/543/090`, `101/891/070`, `101/891/080`, `101/891/090`, `101/892/070`, `101/892/080`, `101/892/090`, `101/893/070`, `101/893/080`, `101/893/090`

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3087-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.