The Recall Desk
ModerateFDA (Devices)·Z-2145-2014·Announced 2014-12-03

Market-Tiers recalls laparoscopic morcellator instructions with missing safety pages

Market-Tiers Inc. is recalling 100 units of the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System because the Instructions for Use omitted critical safety pages.

What this means for you

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 classified as FDA Class II. The hazard is a documentation error (missing safety pages) rather than a physical defect in the device itself, which aligns with the rubric for minor labeling or documentation issues.

Plain-English summary

Market-Tiers Inc. is recalling 100 units of the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011. The recall involves the control units, hand-grips, flexible shafts, trocars, sleeves, valves, and blades. The product was distributed nationwide.

The recall was initiated because some pages of the Instructions for Use were omitted. Specifically, the missing pages included information regarding Indications for Use, Warnings, and Contraindications. The affected Instructions for Use are version 02.08.2012 and were provided with control units bearing specific serial numbers listed in the recall documentation.

Healthcare facilities and users should stop using the affected Instructions for Use and contact Market-Tiers Inc. for replacement documentation. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
Manufacturer
Market-Tiers Inc
Affected units
100

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)

  • 6283800-002
  • 6283800-004
  • 6283800-010
  • 6283800-023
  • 6823800-045
  • 6283800-008
  • 6283800-011
  • 6283800-013
  • 7010201-017
  • 6283800-014
  • 6283800-016
  • 6283800-017
  • 6283800-019
  • 6283800-020
  • 6283800-021
  • 6283800-022
  • 6283800-029
  • 6283800-024
  • 6283800-026
  • 6283800-027

Distribution

Distributed nationwide across the United States.