The Recall Desk
LowFDA (Devices)·Z-0538-2015·Announced 2014-12-17

Instrumed Recalls Mogen Circumcision Clamps for Regulatory Non-Compliance

Instrumed International is withdrawing 421 Mogen circumcision clamps because the company did not market these devices prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

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 driven by regulatory documentation and marketing compliance issues rather than a physical defect or reported health hazard, fitting the criteria for a Low severity recall.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 421 Mogen Circumcision Clamps from the market. These medical instruments are used to compress the foreskin of the penis during the circumcision of male infants. The devices were distributed nationwide to locations in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

The recall was initiated because Instrumed did not market these specific devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The affected products are sold under various trade names, including Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion.

Healthcare facilities and distributors should stop using the affected clamps and contact Instrumed International for further instructions. Consumers who have purchased these devices should contact their healthcare provider or the manufacturer for guidance on proper disposal or replacement.

The recalled product

Product
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
421

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: Mogen Circumcision Clamp
  • Instrumed Product Number: 330-86212
  • Trade Name: Teleflex Medical
  • Teleflex Medical Product Name: CLAMP MOGEN
  • Teleflex Medical Item Number: P-16310
  • Lot Numbers: 010214
  • 030113
  • 050114
  • 060313
  • 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Mogan Circumcision Clamp
  • infant
  • Boss Instruments Item Number: 46-5190
  • Lot Numbers: 030113
  • 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp
  • Trade Name: Millennium Surgical
  • Millennium Surgical Product Name: Mogan Circumcision Clamp
  • Millennium Surgical Item Number: 0-64227
  • 030112

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 →

Related recalls

Same manufacturer · Instrumed International, Inc.

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Same hazard · regulatory non compliance

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