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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Synergetics Inc: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Agency Publication Date: October 18, 2016
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Affected Products

Product: 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Lot number M545040 (1 each or box of 6 each), exp 10/2018 Lot number M586070 (1 each or box of 6 each), exp 03/2019

Lot Numbers:
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Product: 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019

Lot Numbers:
number
number
Product: 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Lot number M543990 (1 each or box of 6 each), exp 10/2018 Lot number M545780 (1 each or box of 6 each), exp 10/2018 Lot number M569020 (1 each or box of 6 each), exp 01/2019 Lot number M578140 (1 each or box of 6 each), exp 02/2019

Lot Numbers:
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number
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Product: 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.

Lot number M546500 (1 each or box of 6 each), exp 10/2018

Lot Numbers:
number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74918
Status: Resolved
Manufacturer: Synergetics Inc
Manufactured In: United States
Units Affected: 4 products (72 units; 72 units; 255 units; 9 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.