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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
Related recalls
Same hazard · documentation error
See all →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- SevereLumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections
FDA (Devices) · 2013-02-20
- ModerateStryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error
FDA (Devices) · 2014-12-24
- ModerateTENS Devices Recalled for Missing Instruction Manual Warnings
FDA (Devices) · 2023-12-13
- ModerateNico Corp. Recalls Myriad Handpiece Tissue Morcellators Due to Defective Component
FDA (Devices) · 2016-06-29
- ModerateStryker Endoscopy Recalls 5mm Metzenbaum Scissors Due to Sterilization Labeling Error
FDA (Devices) · 2014-12-24
- ModerateCook Inc. Recalls Endoscopic Introducer/Extractor Due to Inadequate Reprocessing Instructions
FDA (Devices) · 2017-06-21