Agency classClass IIOur severity:High FDA (Devices)·Z-2316-2015·Announced 2015-08-05

Symmetry Surgical Disposable Towel Clamp Recalled for Sterility Assurance

Symmetry Surgical is recalling 2,708 units of disposable towel clamps due to a lack of sterility assurance. The affected sterile products were distributed in the US, Germany, and Mexico.

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 3/5 (High).

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 is classified as FDA Class II and involves a risk-of-harm product (lack of sterility assurance) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Symmetry Surgical, Inc. is recalling 2,708 units of its SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP (REF 19-4137). The recall is being conducted because the products lack sterility assurance. These items are sterile, ethylene oxide (EO) sterilized, and require a prescription (Rx only).

The affected products were distributed worldwide, including in the United States (specifically CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA), Germany, and Mexico. The recall covers specific lot codes, including 149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.

Healthcare facilities and consumers should stop using the affected towel clamps and contact Symmetry Surgical, Inc. for further instructions or a return.

The recalled product

Product: SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.
Manufacturer: Symmetry Surgical, Inc.
Category: Medical Device — Surgical Supplies
Hazard: lack-of-sterility
Affected units: 2,708

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)

149053
149129
149143
149604
149605
149606
149682
149692
149837
149853
154454
154455
154456
154457
185696
228161
229609
230233
259154
259156

Distribution

Distributed in 18 states:

Same manufacturer · Symmetry Surgical, Inc.

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Same hazard · lack of sterility