The Recall Desk
LowFDA (Devices)·Z-0558-2015·Announced 2014-12-17

Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance

Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.

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 Low severity.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 23 Schiotz tonometers from the market. These manual devices are used to measure intraocular pressure and are sold under the brand names Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries. 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 non-compliance. 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 source text does not report any illnesses, injuries, or deaths associated with the use of these tonometers.

Healthcare providers and consumers should stop using the affected tonometers and contact Instrumed International for further instructions on the withdrawal.

The recalled product

Product
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Ophthalmic Instruments
Hazard
Affected units
23

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: Schoitz Tonometer
  • Instrumed Product Number: 720-55800
  • Trade Name: Millennium Surgical
  • Millennium Surgical Product Name: Schoitz Tonometer
  • Millennium Surgical Item Number: 3-5754
  • Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: Schoitz Tonometer
  • Symmetry Surgical Item Number: 60-6031
  • Lot Numbers: 030212
  • 030413
  • 040113
  • 100312
  • 120113. 3) Instrumed Product Name: Schoitz Tonometer
  • Trade Name: Accutome
  • Accutome Product Name: Schoitz Tonometer
  • Accutome Item Number: AM0530
  • Lot Number: 030212
  • 120113. 4) Instrumed Product Name: Schoitz Tonometer
  • Trade Name: Boss Instruments

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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