CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report

Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile recalled

Teleflex Medical is recalling Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical, distributed nationwide in the US. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.

Quantity recalled233,641 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0246-2016
FDA event ID: 72037
Recalling firm: Teleflex Medical, Research Triangle Park, NC
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2015
FDA classified: 6 Nov 2015
Reported: 18 Nov 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

24 Aug 2015	Recall initiated by company
6 Nov 2015	Classified by FDA	+74 days
18 Nov 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.

Where it was distributed

Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guyana, Hong Kong, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Martinique, Netherlands, Panama, Peru, Poland, Portugal, Reunion, Romania, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Venezuela, and the United Arab Emirates.

Nationwide

Questions about this recall

Why was it recalled?

Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

Which lots are affected?

Material #503700-000060, Batch numbers: 13IG21, 13LG06, 14AG04, 14FG06, 14GG01, 14LG06, 15AG28, 15CG24 and 15DG38.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 72037

Reported	Class	Recall	Company	Reason	Where
18 Nov 2015	CLASS II	R¿sch Flexi-Slip Endotracheal Tube Stylet recalled by Teleflex Medical	Teleflex Medical	Foreign Material	Nationwide

More recalls from Teleflex Medical

All 235

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
1 Jun 2022Device	CLASS II	Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

Other Other Medical Devices recalls

All 13,817

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Blood Culture Collection Venipuncture Kit 20/Cs recalled	Medical Action Industries Inc. 306	Sterility	Nationwide
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide