FDA Device recall Z-3088-2024

smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Per…

FDA Device
Class I
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class I recall of smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Per… 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-3088-2024
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 BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080; 3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090; 4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070; 5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080; 6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090; 7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070; 8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080; 9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090; 10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070; 11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080; 12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090

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	101/561/070, Lot Number 3887555; 101/561/070, Lot Number 3928959; 101/561/070, Lot Number 4005346; 101/561/070, Lot… 101/561/070, Lot Number 3887555; 101/561/070, Lot Number 3928959; 101/561/070, Lot Number 4005346; 101/561/070, Lot Number 4217858; 101/561/070, Lot Number 4234862; 101/561/070, Lot Number 4266405; 101/561/070, Lot Number 4348810; 101/561/080, Lot Number 3887536; 101/561/080, Lot Number 3906566; 101/561/080, Lot Number 3906567; 101/561/080, Lot Number 3906568; 101/561/080, Lot Number 4217859; 101/561/080, Lot Number 4232677; 101/561/080, Lot Number 4238252; 101/561/080, Lot Number 4249230; 101/561/080, Lot Number 4281149; 101/561/080, Lot Number 4281150; 101/561/080, Lot Number 4283700; 101/561/080, Lot Number 4285877; 101/561/080, Lot Number 4288974; 101/561/080, Lot Number 4291189; 101/561/080, Lot Number 4304152; 101/561/080, Lot Number 4308334; 101/561/080, Lot Number 4348877; 101/561/080, Lot Number 4348878; 101/561/080, Lot Number 4348879; 101/561/080, Lot Number 4348883; 101/561/080, Lot Number 4348884; 101/561/080, Lot Number 4348885; 101/561/080, L

code_info

101/561/070, Lot Number 3887555; 101/561/070, Lot Number 3928959; 101/561/070, Lot Number 4005346; 101/561/070, Lot…

101/561/070, Lot Number 3887555; 101/561/070, Lot Number 3928959; 101/561/070, Lot Number 4005346; 101/561/070, Lot Number 4217858; 101/561/070, Lot Number 4234862; 101/561/070, Lot Number 4266405; 101/561/070, Lot Number 4348810; 101/561/080, Lot Number 3887536; 101/561/080, Lot Number 3906566; 101/561/080, Lot Number 3906567; 101/561/080, Lot Number 3906568; 101/561/080, Lot Number 4217859; 101/561/080, Lot Number 4232677; 101/561/080, Lot Number 4238252; 101/561/080, Lot Number 4249230; 101/561/080, Lot Number 4281149; 101/561/080, Lot Number 4281150; 101/561/080, Lot Number 4283700; 101/561/080, Lot Number 4285877; 101/561/080, Lot Number 4288974; 101/561/080, Lot Number 4291189; 101/561/080, Lot Number 4304152; 101/561/080, Lot Number 4308334; 101/561/080, Lot Number 4348877; 101/561/080, Lot Number 4348878; 101/561/080, Lot Number 4348879; 101/561/080, Lot Number 4348883; 101/561/080, Lot Number 4348884; 101/561/080, Lot Number 4348885; 101/561/080, 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-3088-2024%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.