The Recall Desk
LowFDA (Devices)·Z-2587-2017·Announced 2017-06-21

Teleflex Recalls Sheridan Intubating Stylets Due to Incorrect Size Labeling

Teleflex Medical is recalling Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets because the product size listed on the labeling is incorrect.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as Low severity because the source text identifies the issue solely as an incorrect product size on the labeling, which falls under the rubric criteria for cosmetic defects or documentation issues without reported injury or significant health risk.

Plain-English summary

Teleflex Medical is recalling Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets. These medical devices are intubating stylets manufactured from galvanized carbon steel and aluminum rods, coated with a blue PVC or polypropylene outer covering, and designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.

The recall was initiated because the product size listed on the labeling is incorrect. The affected units are identified by Product Code 5-15103 and specific lot numbers: 73J1600218, 73K1600376, 73K1600587, 73L1600158, 73M1600275, and 73A1700733. A total of 21,690 units were distributed.

The affected products were distributed worldwide, including nationwide in the United States in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, and UT, as well as in Canada, the Czech Republic, Denmark, Germany, Israel, and Portugal. Healthcare facilities and consumers should stop using these specific stylets and contact Teleflex Medical for further instructions.

The recalled product

Product
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired sh
Manufacturer
Teleflex Medical
Affected units
21,690

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 (6)

  • Product Code 5-15103 - Lot Number 73J1600218
  • 73K1600376
  • 73K1600587
  • 73L1600158
  • 73M1600275
  • 73A1700733

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically: