---
title: "smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BL... — FDA record Z-3086-2024 | Is It on Recall"
description: "There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUper"
url: https://isitonrecall.com/recall/fda-device-z-3086-2024-smiths-medical-portex-bluselect-tracheostomy-tube-labeled-as-follows-1-bluselect-6-0-cuffed-non-fen/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Ite... — FDA record Z-3086-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 7, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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, F...
- **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.
- **Classification**: Class I
- **Recalling firm**: Smiths Medical ASD Inc.
- **Quantity**: 799732 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-3086-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3086-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 4034825; 101/800/075CZ, Lot Number 4037974; 101/800/075CZ, Lot Number 4073768; 101/800/075CZ, Lot Number 4117927; 101/800/075CZ, Lot Number 4134827; 101/800/075CZ, Lot Number 4152439; 101/800/075CZ, Lot Number 4156970; 101/800/075CZ, Lot Number 4238234; 101/800/075CZ, Lot Number 4249234; 101/800/075CZ, Lot Number 4348898; 101/800/075CZ, Lot Number 4348899; 101/800/075CZ, Lot Number 4365892; 101/800/080CZ, Lot Number 3895103; 101/800/080CZ, Lot Number 3909670; 101/800/080CZ, Lot Number 3933044; 101/800/080CZ, Lot Number 4037971; 101/800/080CZ, Lot Number 4052621; 101/800/080CZ, Lot Number 4138225; 101/800/080CZ, Lot Number 4156969; 101/800/080CZ, Lot Number 4224695; 101/800/080CZ, Lot Number 4230078; 101/800/080CZ, Lot Number 4232686; 101/800/080CZ, Lot Number 4245469; 101/800/080CZ, Lot Number 4247407; 101/800/080CZ, Lot Number 4270931; 101/800/080CZ, Lot Number 4291190; 101/800/080CZ, Lot Number 4305933; 101/800/080CZ, Lot Number 4305934; 101/800/080CZ, Lot Number 4305935; 101/800/080CZ, Lot Number 4305936; 101/800/080CZ, Lot Number 4305938; 101/800/085CZ, Lot Number 3922027; 101/800/085CZ, Lot Number 3951221; 101/800/085CZ, Lot Number 4034824; 101/800/085CZ, Lot Number 4256383; 101/800/085CZ, Lot Number 4348861; 101/800/090CZ, Lot Number 3895099; 101/800/090CZ, Lot Number 3951220; 101/800/090CZ, Lot Number 3968406; 101/800/090CZ, Lot Number 4039797; 101/800/090CZ, Lot Number 4197025; 101/800/090CZ, Lot Number 4217803; 101/800/090CZ, Lot Number 4238236; 101/800/090CZ, Lot Number 4261648; 101/800/090CZ, Lot Number 4273231; 101/800/090CZ, Lot Number 4306047; 101/800/090CZ, Lot Number 4310439; 101/800/090CZ, Lot Number 4376612; 101/800/090CZ, Lot Number 4387369; 101/800/100CZ, Lot Number 3895110; 101/800/100CZ, Lot Number 3951219; 101/800/100CZ, Lot Number 4000129; 101/800/100CZ, Lot Number 4230076; 101/800/100CZ, Lot Number 4306058; 101/800/100CZ, Lot Number 4372161; 101/800/100CZ, Lot Number 4386600; 101/800/100CZ, Lot Number 4390744; 101/800/100CZ, Lot Number 4413606; 101/802/060CZ, Lot Number 3906886; 101/802/060CZ, Lot Number 3925839; 101/802/060CZ, Lot Number 4028452; 101/802/060CZ, Lot Number 4382046; 101/802/070CZ, Lot Number 3895109; 101/802/070CZ, Lot Number 3925740; 101/802/070CZ, Lot Number 3972531; 101/802/075CZ, Lot Number 3895104; 101/802/075CZ, Lot Number 3951183; 101/802/075CZ, Lot Number 3968265; 101/802/075CZ, Lot Number 4388729; 101/802/080CZ, Lot Number 3895105; 101/802/080CZ, Lot Number 3951185; 101/802/080CZ, Lot Number 4268672; 101/802/080CZ, Lot Number 4310441; 101/802/080CZ, Lot Number 4423828; 101/802/080CZ, Lot Number 4436040; 101/802/080CZ, Lot Number 4444762; 101/802/080CZ, Lot Number 4456953; 101/802/085CZ, Lot Number 3922029; 101/802/085CZ, Lot Number 3925759; 101/802/085CZ, Lot Number 4028454; 101/802/090CZ, Lot Number 3895106; 101/802/090CZ, Lot Number 3925752; 101/802/090CZ, Lot Number 3954847; 101/802/100CZ, Lot Number 3910328; 101/802/100CZ, Lot Number 3951214; 101/802/100CZ, Lot Number 3968282; 101/810/060CZ, Lot Number 3887495; 101/810/060CZ, Lot Number 3933190; 101/810/060CZ, Lot Number 3948313; 101/810/060CZ, Lot Number 3958315; 101/810/060CZ, Lot Number 4106722; 101/810/060CZ, Lot Number 4268673; 101/810/070CZ, Lot Number 3887478; 101/810/070CZ, Lot Number 4106813; 101/810/070CZ, Lot Number 4243097; 101/810/070CZ, Lot Number 4254571; 101/810/070CZ, Lot Number 4285856; 101/810/075, Lot Number 4271670; 101/810/075CZ, Lot Number 3887504; 101/810/075CZ, Lot Number 3925795; 101/810/075CZ, Lot Number 4010055; 101/810/075CZ, Lot Number 4073763; 101/810/075CZ, Lot Number 4177908; 101/810/075CZ, Lot Number 4222083; 101/810/075CZ, Lot Number 4249233; 101/810/075CZ, Lot Number 4281153; 101/810/075CZ, Lot Number 4381994; 101/810/075CZ, Lot Number 4412129; 101/810/080, Lot Number 3900816; 101/810/080CZ, Lot Number 3887481; 101/810/080CZ, Lot Number 4173265; 101/810/080CZ, Lot Number 4207825; 101/810/080CZ, Lot Number 4217114; 101/810/080CZ, Lot Number 4230143; 101/810/080CZ, Lot Number 4285773; 101/810/080CZ, Lot Number 4306016; 101/810/080CZ, Lot Number 4312272; 101/810/080CZ, Lot Number 4381980; 101/810/080CZ, Lot Number 4387365; 101/810/080CZ, Lot Number 4403461; 101/810/080CZ, Lot Number 4415817; 101/810/080CZ, Lot Number 4423832; 101/810/085CZ, Lot Number 3922028; 101/810/085CZ, Lot Number 3951211; 101/810/085CZ, Lot Number 3989280; 101/810/085CZ, Lot Number 4067915; 101/810/085CZ, Lot Number 4098973; 101/810/085CZ, Lot Number 4152435; 101/810/085CZ, Lot Number 4178022; 101/810/085CZ, Lot Number 4281079; 101/810/085CZ, Lot Number 4306011; 101/810/090CZ, Lot Number 3887482; 101/810/090CZ, Lot Number 3993623; 101/810/090CZ, Lot Number 4106736; 101/810/090CZ, Lot Number 4173266; 101/810/090CZ, Lot Number 4243117; 101/810/090CZ, Lot Number 4306027; 101/810/090CZ, Lot Number 4327669; 101/810/090CZ, Lot Number 4403367; 101/810/090CZ, Lot Number 4426600; 101/810/090CZ, Lot Number 4458561; 101/810/100CZ, Lot Number 3887505; 101/810/100CZ, Lot Number 3909242; 101/810/100CZ, Lot Number 4058669; 101/810/100CZ, Lot Number 4175497; 101/810/100CZ, Lot Number 4217875; 101/810/100CZ, Lot Number 4249333; 101/810/100CZ, Lot Number 4291208; 101/810/100CZ, Lot Number 4310443; 101/810/100CZ, Lot Number 4312263; 101/810/100CZ, Lot Number 4387368; 101/810/100CZ, Lot Number 4397557; 101/812/060CZ, Lot Number 3887479; 101/812/060CZ, Lot Number 3925779; 101/812/060CZ, Lot Number 3959080; 101/812/060CZ, Lot Number 3976752; 101/812/060CZ, Lot Number 4106752; 101/812/060CZ, Lot Number 4294444; 101/812/070CZ, Lot Number 3887499; 101/812/070CZ, Lot Number 3925781; 101/812/070CZ, Lot Number 3948188; 101/812/070CZ, Lot Number 3968279; 101/812/070CZ, Lot Number 4106754; 101/812/070CZ, Lot Number 4242910; 101/812/075CZ, Lot Number 3887552; 101/812/075CZ, Lot Number 3968280; 101/812/075CZ, Lot Number 4217831; 101/812/075CZ, Lot Number 4268677; 101/812/075CZ, Lot Number 4381979; 101/812/075CZ, Lot Number 4413594; 101/812/080CZ, Lot Number 3887488; 101/812/080CZ, Lot Number 3948295; 101/812/080CZ, Lot Number 3989255; 101/812/080CZ, Lot Number 4073770; 101/812/080CZ, Lot Number 4106756; 101/812/080CZ, Lot Number 4227246; 101/812/080CZ, Lot Number 4234757; 101/812/080CZ, Lot Number 4385065; 101/812/085CZ, Lot Number 3922030; 101/812/085CZ, Lot Number 3925793; 101/812/085CZ, Lot Number 4028504; 101/812/085CZ, Lot Number 4191164; 101/812/085CZ, Lot Number 4222085; 101/812/085CZ, Lot Number 4261649; 101/812/085CZ, Lot Number 4382043; 101/812/090CZ, Lot Number 3887489; 101/812/090CZ, Lot Number 3972311; 101/812/090CZ, Lot Number 4075795; 101/812/090CZ, Lot Number 4106757; 101/812/090CZ, Lot Number 4170983; 101/812/090CZ, Lot Number 4217120; 101/812/090CZ, Lot Number 4243118; 101/812/100CZ, Lot Number 3887507; 101/812/100CZ, Lot Number 3948187; 101/812/100CZ, Lot Number 4064797; 101/812/100CZ, Lot Number 4245460; 101/812/100CZ, Lot Number 4259283; 101/812/100CZ, Lot Number 4381995; 101/812/100CZ, Lot Number 4388732; 101/812/100CZ, Lot Number 4413618; 101/812/100CZ, Lot Number 4423838; 101/812/100CZ, Lot Number 4443290; 101/815/060, Lot Number 3933722; 101/815/060, Lot Number 3940999; 101/815/060, Lot Number 3949223; 101/815/060, Lot Number 4014730; 101/815/060, Lot Number 4021067; 101/815/060, Lot Number 4035539; 101/815/060, Lot Number 4091934; 101/815/060, Lot Number 4118283; 101/815/060, Lot Number 4121883; 101/815/060, Lot Number 4159150; 101/815/060, Lot Number 4164109; 101/815/060, Lot Number 4166710; 101/815/060, Lot Number 4174793; 101/815/060, Lot Number 4177293; 101/815/060, Lot Number 4177295; 101/815/060, Lot Number 4187097; 101/815/060, Lot Number 4269270; 101/815/060, Lot Number 4369411; 101/815/060, Lot Number 4369412; 101/815/060, Lot Number 4380967; 101/815/070, Lot Number 3905154; 101/815/070, Lot Number 3949269; 101/815/070, Lot Number 3965244; 101/815/070, Lot Number 4032511; 101/815/070, Lot Number 4039241; 101/815/070, Lot Number 4091935; 101/815/070, Lot Number 4115649; 101/815/070, Lot Number 4121851; 101/815/070, Lot Number 4131921; 101/815/070, Lot Number 4187074; 101/815/070, Lot Number 4187085; 101/815/070, Lot Number 4196637; 101/815/070, Lot Number 4214909; 101/815/070, Lot Number 4219471; 101/815/070, Lot Number 4220399; 101/815/070, Lot Number 4223153; 101/815/070, Lot Number 4260338; 101/815/070, Lot Number 4277368; 101/815/070, Lot Number 4292624; 101/815/070, Lot Number 4294949; 101/815/070, Lot Number 4306727; 101/815/070, Lot Number 4306851; 101/815/070, Lot Number 4306852; 101/815/070, Lot Number 4332676; 101/815/070, Lot Number 4332678; 101/815/070, Lot Number 4332684; 101/815/070, Lot Number 4336640; 101/815/070, Lot Number 4369413; 101/815/075, Lot Number 3956297; 101/815/075, Lot Number 4071378; 101/815/075, Lot Number 4126686; 101/815/075, Lot Number 4174782; 101/815/075, Lot Number 4294945; 101/815/075, Lot Number 4332682; 101/815/075, Lot Number 4362485; 101/815/075, Lot Number 4414625; 101/815/075, Lot Number 4428012; 101/815/080, Lot Number 3905015; 101/815/080, Lot Number 3940109; 101/815/080, Lot Number 3942887; 101/815/080, Lot Number 3965245; 101/815/080, Lot Number 4021055; 101/815/080, Lot Number 4029161; 101/815/080, Lot Number 4058347; 101/815/080, Lot Number 4100474; 101/815/080, Lot Number 4118284; 101/815/080, Lot Number 4169838; 101/815/080, Lot Number 4187081; 101/815/080, Lot Number 4190342; 101/815/080, Lot Number 4192320; 101/815/080, Lot Number 4202303; 101/815/080, Lot Number 4204265; 101/815/080, Lot Number 4204266; 101/815/080, Lot Number 4206466; 101/815/080, Lot Number 4209172; 101/815/080, Lot Number 4274832; 101/815/080, Lot Number 4294948; 101/815/080, Lot Number 4336646; 101/815/080, Lot Number 4336649; 101/815/080, Lot Number 4336668; 101/815/085, Lot Number 3956296; 101/815/085, Lot Number 4071392; 101/815/085, Lot Number 4090264; 101/815/085, Lot Number 4209173; 101/815/085, Lot Number 4332683; 101/815/085, Lot Number 4369414; 101/815/090, Lot Number 3933809; 101/815/090, Lot Number 3949146; 101/815/090, Lot Number 4011017; 101/815/090, Lot Number 4021088; 101/815/090, Lot Number 4026491; 101/815/090, Lot Number 4076707; 101/815/090, Lot Number 4159151; 101/815/090, Lot Number 4169840; 101/815/090, Lot Number 4169841; 101/815/090, Lot Number 4178241; 101/815/090, Lot Number 4185327; 101/815/090, Lot Number 4200170; 101/815/090, Lot Number 4200171; 101/815/090, Lot Number 4204267; 101/815/090, Lot Number 4212316; 101/815/090, Lot Number 4216557; 101/815/090, Lot Number 4260339; 101/815/090, Lot Number 4279525; 101/815/090, Lot Number 4294947; 101/815/090, Lot Number 4334212; 101/815/090, Lot Number 4336647; 101/815/090, Lot Number 4336650; 101/815/100, Lot Number 3933697; 101/815/100, Lot Number 4021081; 101/815/100, Lot Number 4029154; 101/815/100, Lot Number 4112822; 101/815/100, Lot Number 4148895; 101/815/100, Lot Number 4161638; 101/815/100, Lot Number 4169842; 101/815/100, Lot Number 4187096; 101/815/100, Lot Number 4192321; 101/815/100, Lot Number 4206174; 101/815/100, Lot Number 4284378; 101/817/060, Lot Number 3905152; 101/817/060, Lot Number 41... |

The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3086-2024%22).

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 18, 2024
- **Recall initiation date**: Jun 7, 2024
- **Center classification date**: Sep 11, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3086-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical ASD Inc. records](https://isitonrecall.com/brand/smiths-medical-asd-inc/)