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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Teleflex Medical
- Hazard
- 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
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