FDA Device recall Z-3086-2024

smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ

FDA Device
Class I
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class I recall of smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ 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-3086-2024
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 BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ; 5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ; 6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ; 7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ; 8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ; 9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ; 10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ; 11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ; 12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ; 13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ; 14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ; 15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ; 16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ; 17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075; 18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ; 19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080; 20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ; 21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ; 22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ; 23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ; 24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ; 25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ; 26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ; 27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ; 28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ; 29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ; 30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ; 31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060; 32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070; 33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075; 34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080; 35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085; 36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090; 37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100; 38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060; 39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070; 40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080; 41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090; 42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100; 43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ; 44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ; 45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ; 46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ; 47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ; 48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ; 49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ; 50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ; 51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ; 52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ; 53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0

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	101/800/060CZ, Lot Number 3895097; 101/800/060CZ, Lot Number 3925835; 101/800/060CZ, Lot Number 4025600; 101/800/060… 101/800/060CZ, Lot Number 3895097; 101/800/060CZ, Lot Number 3925835; 101/800/060CZ, Lot Number 4025600; 101/800/060CZ, Lot Number 4106716; 101/800/060CZ, Lot Number 4230149; 101/800/060CZ, Lot Number 4252500; 101/800/060CZ, Lot Number 4382002; 101/800/070CZ, Lot Number 3895101; 101/800/070CZ, Lot Number 3925960; 101/800/070CZ, Lot Number 3933088; 101/800/070CZ, Lot Number 4010050; 101/800/070CZ, Lot Number 4022790; 101/800/070CZ, Lot Number 4034826; 101/800/070CZ, Lot Number 4037975; 101/800/070CZ, Lot Number 4133612; 101/800/070CZ, Lot Number 4152440; 101/800/070CZ, Lot Number 4156971; 101/800/070CZ, Lot Number 4217804; 101/800/070CZ, Lot Number 4238237; 101/800/070CZ, Lot Number 4249341; 101/800/070CZ, Lot Number 4305944; 101/800/070CZ, Lot Number 4305947; 101/800/070CZ, Lot Number 4368641; 101/800/075CZ, Lot Number 3895100; 101/800/075CZ, Lot Number 3925748; 101/800/075CZ, Lot Number 3933086; 101/800/075CZ, Lot Number 4025599; 101/800/075CZ, Lot Number 40

code_info

101/800/060CZ, Lot Number 3895097; 101/800/060CZ, Lot Number 3925835; 101/800/060CZ, Lot Number 4025600; 101/800/060…

101/800/060CZ, Lot Number 3895097; 101/800/060CZ, Lot Number 3925835; 101/800/060CZ, Lot Number 4025600; 101/800/060CZ, Lot Number 4106716; 101/800/060CZ, Lot Number 4230149; 101/800/060CZ, Lot Number 4252500; 101/800/060CZ, Lot Number 4382002; 101/800/070CZ, Lot Number 3895101; 101/800/070CZ, Lot Number 3925960; 101/800/070CZ, Lot Number 3933088; 101/800/070CZ, Lot Number 4010050; 101/800/070CZ, Lot Number 4022790; 101/800/070CZ, Lot Number 4034826; 101/800/070CZ, Lot Number 4037975; 101/800/070CZ, Lot Number 4133612; 101/800/070CZ, Lot Number 4152440; 101/800/070CZ, Lot Number 4156971; 101/800/070CZ, Lot Number 4217804; 101/800/070CZ, Lot Number 4238237; 101/800/070CZ, Lot Number 4249341; 101/800/070CZ, Lot Number 4305944; 101/800/070CZ, Lot Number 4305947; 101/800/070CZ, Lot Number 4368641; 101/800/075CZ, Lot Number 3895100; 101/800/075CZ, Lot Number 3925748; 101/800/075CZ, Lot Number 3933086; 101/800/075CZ, Lot Number 4025599; 101/800/075CZ, Lot Number 40

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-3086-2024%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.