Instrumed Recalls Schoitz Weights for Regulatory Compliance Issues
Instrumed International is withdrawing Schoitz weights from the market 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 Schoitz weights from the market. These manual devices are used with Schoitz tonometers to measure intraocular pressure or tension and are sold under the Ambler Surgical brand name. The recall involves specific 7.5-gram and 15.0-gram weights with lot number 050411.
The reason for the withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. This is a regulatory compliance issue rather than a report of product malfunction or patient injury.
The affected products were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Consumers and healthcare providers should stop using the affected weights and contact Instrumed International for further instructions or a refund.
The recalled product
- Product
- Schoitz weights are manual devices used with Schoitz tonometers and are 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 (app
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 3
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 (10)
- 1) Instrumed Product Name: Schoitz Weights 7.5 grams
- Instrumed Product Number: 720-55812
- Trade Name: Ambler Surgical
- Ambler Surgical Product Name: Schoitz Weights 7.5 grams
- Ambler Surgical Item Number: 5754B
- Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams
- Instrumed Product Number: 720-55822
- Ambler Surgical Product Name: Schoitz Weights 15.0 grams
- Ambler Surgical Item Number: 5754F
- Lot Number: 050411.
Distribution
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.
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