ShileyRecalls & reported problems across all models
Covidien LP · 387 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one Shiley model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9,392
- Deaths reported
- 78
- Injuries reported
- 1,588
- Recalls
- 5
We found 387 models of Shiley by Covidien LP in the FDA's device registry (GUDID). Together they are named in 9,392 adverse event reports in the FDA's MAUDE database, received between May 9, 2016 and Sep 29, 2026 — classified as 78 deaths, 1,588 injuries, 7,726 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (3,587 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Shiley recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 23, 2026Open, Classified
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
Z-2653-2026 · Root cause: Labeling Change Control · names 13 of these models · Recall details · FDA record ↗
- Apr 15, 2026Open, Classified
Due to customer complaint regarding incorrect display box labeling.
Z-2261-2026 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2025Open, Classified
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
Z-1390-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 24, 2023Open, Classified
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Z-1357-2023 · Root cause: Component change control · names 38 of these models · Recall details · FDA record ↗
- Feb 10, 2023Open, Classified
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
Z-1318-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported Shiley problems
Device problems
- Use of Device Problem3,587
- Gas/Air Leak2,420
- Material Split, Cut or Torn858
- Defective Component767
- Disconnection457
- Inflation Problem331
- Connection Problem330
- Human-Device Interface Problem193
Patient problems
- No Clinical Signs, Symptoms or Conditions3,861
- Unintended Extubation3,167
- Extubate794
- No Patient Involvement718
- Insufficient Information599
- No Consequences Or Impact To Patient343
- Low Oxygen Saturation212
- No Information193
Shiley models
387 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Shiley 18875Tube, tracheal (w/wo connector)4 deaths570 reports
- Shiley 18775Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 8CN85HTube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 18880Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 6CN75HTube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 18780Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770STube, tracheal (w/wo connector)273 reports
- Shiley 18780STube, tracheal (w/wo connector)251 reports
- Shiley 7CN80RTube tracheostomy and tube cuff2 recalls148 reports
- Shiley 125037TUBE, BRONCHIAL (W/WO CONNECTOR)1 death209 reports
- Shiley 18870Tube, tracheal (w/wo connector)1 death202 reports
- Shiley 86113Tube, tracheal (w/wo connector)16 deaths186 reports
- Shiley 86112Tube, tracheal (w/wo connector)1 death181 reports
- Shiley 6CN75RTube tracheostomy and tube cuff1 recall1 death121 reports
- Shiley 6FENTube tracheostomy and tube cuff1 recall106 reports
- Shiley 18765Tube, tracheal (w/wo connector)141 reports
- Shiley 8CN85RTube tracheostomy and tube cuff1 recall86 reports
- Shiley 86051Tube, tracheal (w/wo connector)1 recall77 reports
- Shiley 18775STube, tracheal (w/wo connector)125 reports
- Shiley 8CN85ATube tracheostomy and tube cuff1 recall74 reports
- Shiley 6UN75HTube tracheostomy and tube cuff1 recall70 reports
- Shiley 5.5PCFTube tracheostomy and tube cuff114 reports
- Shiley 125035TUBE, BRONCHIAL (W/WO CONNECTOR)114 reports
- Shiley 7CN80ATube tracheostomy and tube cuff1 recall60 reports
- Shiley 8DCTTube tracheostomy and tube cuff2 deaths104 reports
- Shiley 6CN75ATube tracheostomy and tube cuff1 recall47 reports
- Shiley CAPTube tracheostomy and tube cuff90 reports
- Shiley 4CN65HTube tracheostomy and tube cuff1 recall1 death31 reports
- Shiley 7CN80HTube tracheostomy and tube cuff1 recall1 death28 reports
- Shiley 8DFENTube tracheostomy and tube cuff1 recall26 reports
- Shiley 5CN70RTube tracheostomy and tube cuff1 recall1 death22 reports
- Shiley 5.0PCFTube tracheostomy and tube cuff69 reports
- Shiley 6CFNTube tracheostomy and tube cuff67 reports
- Shiley 10CN10RTube tracheostomy and tube cuff1 recall16 reports
- Shiley 6DCFSTube tracheostomy and tube cuff1 recall16 reports
- Shiley 18880STube, tracheal (w/wo connector)65 reports
- Shiley 6UN75RTube tracheostomy and tube cuff1 recall14 reports
- Shiley 5CN70HTube tracheostomy and tube cuff1 recall14 reports
- Shiley 8FENTube tracheostomy and tube cuff2 deaths64 reports
- Shiley 4CN65RTube tracheostomy and tube cuff1 recall11 reports
- Shiley 86452Tube, tracheal (w/wo connector)6 deaths60 reports
- Shiley 6.0PLCFTube tracheostomy and tube cuff60 reports
- Shiley 8UN85HTube tracheostomy and tube cuff1 recall9 reports
- Shiley 4.5PCFTube tracheostomy and tube cuff59 reports
- Shiley 86111Tube, tracheal (w/wo connector)58 reports
- Shiley 4UN65ATube tracheostomy and tube cuff1 recall8 reports
- Shiley 10CN10HTube tracheostomy and tube cuff1 recall7 reports
- Shiley 5CN70ATube tracheostomy and tube cuff1 recall7 reports
- Shiley 4UN65HTube tracheostomy and tube cuff1 recall7 reports
- Shiley 8UN85RTube tracheostomy and tube cuff1 recall6 reports
- Shiley 4UN65RTube tracheostomy and tube cuff1 recall5 reports
- Shiley 6DFENTube tracheostomy and tube cuff1 recall5 reports
- Shiley 7UN80HTube tracheostomy and tube cuff1 recall5 reports
- Shiley 86451Tube, tracheal (w/wo connector)5 deaths55 reports
- Shiley 10DFENTube tracheostomy and tube cuff1 recall4 reports
- Shiley 4CN65ATube tracheostomy and tube cuff1 recall3 reports
- Shiley 5UN70RTube tracheostomy and tube cuff1 recall3 reports
- Shiley 10UN10RTube tracheostomy and tube cuff1 recall3 reports
- Shiley 9CN90HTube tracheostomy and tube cuff1 recall3 reports
- Shiley 4DCFSTube tracheostomy and tube cuff1 recall2 reports
- Shiley 7UN80ATube tracheostomy and tube cuff1 recall2 reports
- Shiley 5UN70HTube tracheostomy and tube cuff1 recall2 reports
- Shiley 8PERCTube, tracheostomy (w/wo connector)2 deaths52 reports
- Shiley 9UN90RTube tracheostomy and tube cuff1 recall1 report
- Shiley 87480Tube, tracheal (w/wo connector)51 reports
- Shiley 6DCFNTube tracheostomy and tube cuff1 recall1 report
- Shiley 8DCFNTube tracheostomy and tube cuff1 recall1 report
- Shiley 10UN10HTube tracheostomy and tube cuff1 recall1 report
- Shiley 60XLTCDTube tracheostomy and tube cuff1 death51 reports
- Shiley DDCPTube, tracheostomy (w/wo connector)1 recall1 report
- Shiley 9CN90RTube tracheostomy and tube cuff1 recall0 reports
- Shiley 7UN80RTube tracheostomy and tube cuff1 recall0 reports
- Shiley 10DCFSTube tracheostomy and tube cuff1 recall0 reports
- Shiley 4DCFNTube tracheostomy and tube cuff1 recall0 reports
- Shiley 4DFENTube tracheostomy and tube cuff1 recall0 reports
- Shiley 126035TUBE, BRONCHIAL (W/WO CONNECTOR)50 reports
- Shiley 10UN10ATube tracheostomy and tube cuff1 recall0 reports
- Shiley 5UN70ATube tracheostomy and tube cuff1 recall0 reports
- Shiley 8UN85ATube tracheostomy and tube cuff1 recall0 reports
- Shiley 9UN90HTube tracheostomy and tube cuff1 recall0 reports
- Shiley 10DCFNTube tracheostomy and tube cuff1 recall0 reports
- Shiley 8DCFSTube tracheostomy and tube cuff1 recall0 reports
- Shiley 86234Tube, Tracheal (W/Wo Connector)49 reports
- Shiley 18875STube, tracheal (w/wo connector)49 reports
- Shiley 5.5PDCTube tracheostomy and tube cuff49 reports
- Shiley 87470Tube, tracheal (w/wo connector)46 reports
- Shiley 86233Tube, tracheal (w/wo connector)45 reports
- Shiley 80XLTCDTube tracheostomy and tube cuff2 deaths44 reports
- Shiley 5.5PCFTube tracheostomy and tube cuff42 reports
- Shiley 86233Tube, tracheal (w/wo connector)42 reports
- Shiley 5.5PLCFTube tracheostomy and tube cuff42 reports
- Shiley 6.5PLCFTube tracheostomy and tube cuff42 reports
- Shiley 87475Tube, tracheal (w/wo connector)2 deaths40 reports
- Shiley 125039TUBE, BRONCHIAL (W/WO CONNECTOR)40 reports
- Shiley 6CFSTube tracheostomy and tube cuff2 deaths40 reports
- Shiley 126039TUBE, BRONCHIAL (W/WO CONNECTOR)39 reports
- Shiley 6LPCTube tracheostomy and tube cuff39 reports
- Shiley 18865Tube, tracheal (w/wo connector)37 reports
- Shiley 86052Tube, tracheal (w/wo connector)35 reports
Recent Shiley adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941085 ↗MalfunctionSep 28, 2026Gas/Air Leak
Patient problems: Insufficient Information
MAUDE report 50923422 ↗MalfunctionSep 28, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923027 ↗MalfunctionSep 28, 2026Connection Problem
It was reported that immediately after intubation, four back-to-back 15 mm connector pop-off events occurred in the hospital. The connector would not remain in place. A larger adapter from an 8.5 tube was inserted to prevent further connector pop-off. There was no reported patient outcome.
Patient problems: Insufficient Information
MAUDE report 50914633 ↗MalfunctionSep 27, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910488 ↗InjurySep 25, 2026Material Deformation
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 50904161 ↗MalfunctionSep 25, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50903384 ↗MalfunctionSep 24, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892005 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50891961 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50891939 ↗MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: Unintended Extubation
MAUDE report 50890060 ↗MalfunctionSep 23, 2026Obstruction of Flow
It was reported that secretions could not be effectively aspirated through the subglottic suction line of the tracheostomy tube. The patient coughed up secretions after cuff deflation and the secretions were white in color and ranged from thin to slightly viscous in consistency. The tube was replaced.
Patient problems: Unintended Extubation
MAUDE report 50876187 ↗MalfunctionSep 23, 2026Use of Device Problem
It was reported that the endotracheal tube had a leak in the balloon inflation tube during patient use. The balloon was inflated several times but repeatedly deflated. The product was tested in water to locate the leak. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868803 ↗MalfunctionSep 23, 2026Connection Problem
It was reported that immediately after intubation, four back-to-back 15 mm connector pop-off events occurred in the hospital. The connector would not remain in place. A larger adapter from an 8.5 tube was inserted to prevent further connector pop-off. There was no reported patient outcome.
Patient problems: Insufficient Information
MAUDE report 50867795 ↗InjurySep 22, 2026Obstruction of Flow
Patient problems: Insufficient Information
MAUDE report 50860649 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
- Puritan Bennett119 models · 3,169 reports · 18 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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