The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0532-2015·Announced 2014-12-17

Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance

Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is driven by regulatory compliance and documentation issues rather than a physical safety defect or reported injury, aligning with the criteria for moderate severity.

Plain-English summary

Instrumed International, Inc. is withdrawing 26 uterine tenaculum hooks from the market. These hook-like instruments, used to seize and hold the cervix or fundus, were sold under the CareFusion, Teleflex Medical, and Symmetry Surgical brand names. The affected units were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

The recall is due to regulatory compliance issues rather than a reported safety defect. Instrumed did not market these devices prior to September 26, 1976, and therefore does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The FDA has classified this recall as Class II.

Healthcare facilities and consumers who possess these specific instruments should stop using them and contact Instrumed International for further instructions on the withdrawal process.

The recalled product

Product
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
26

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)

  • 1) Instrumed Product Name: Emmet Tenaculum Hook
  • #1 22.9 mm
  • Instrumed Product Number: 310-21098
  • Trade Name: CareFusion
  • CareFusion Product Name: Emmet Tenaculum Hook
  • CareFusion Item Number: VM29-7112
  • Lot Numbers: 07211
  • 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook
  • Instrumed Product Number: 310-21113
  • Trade Name: TeleFlex Medical
  • Teleflex Medical Product Name: Emmet Tenaculum Hook
  • Teleflex Medical Item Number: VM29-7112
  • Lot Number: 100213. 3) Instrumed Product Name: Emmet Tenaculum Hook
  • #2
  • blunt
  • CareFusion Item Number: VM29-71131X
  • Lot Number: 110110. 4) Instrumed Product Name : Emmet Tenaculum Hook
  • #5
  • Instrumed Product Number: 310-21138
  • Trade Name: Symmetry Surgical

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 28 recalled by Instrumed International, Inc. 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 28 products in this recall →

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