Teleflex Medical Recalls Roesch Flexi-Slip Endotracheal Tube Stylets
Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets because the plastic coating may split or break off.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets with Soft Distal Tip, Sterile, Rx only. The recall is due to reports that the plastic coating of the stylet may split and/or break off from the stylet.
The affected product is Material #502501. The recall includes 233,641 units distributed worldwide, including the United States and numerous international locations. Specific batch numbers are listed in the official recall notice.
Healthcare providers and consumers should stop using the affected stylets and contact Teleflex Medical for instructions on how to return the product.
The recalled product
- Product
- R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
- Manufacturer
- Teleflex Medical
- Affected units
- 233,641
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Material #502501
- Batch numbers: 12EE20
- 12FE26
- 12GE27
- 12IE37
- 12GE30
- 13AG21
- 12LG29
- 12IE36
- 12IE39
- 13DG06
- 12JE41
- 12KE48
- 13BG26
- 13BG36
- 13DG24
- 14FG03
- 14GG01
- 14GG03
- 14HE32
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · material failure
See all →- HighFDA Recalls Surgical Instrument Handle That May Break During Use
FDA (Devices) · 2024-10-02
- HighMedtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
FDA (Devices) · 2019-10-09
- CriticalMedtronic Recalls Sherpa NX Active Guiding Catheters
FDA (Devices) · 2019-10-09
- SevereArjo Passive Clip Sling Recalled for Material Breakage Risk
FDA (Devices) · 2018-12-19
- SeverePega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect
FDA (Devices) · 2014-04-16