Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure in a surgical device) where specific injury reports are not detailed in the source text, fitting the High severity criteria.
Plain-English summary
Unimed Surgical Products, Inc. initiated a recall on June 16, 2010, for Medline Industries, Inc. electrosurgical electrodes. The recall was initiated due to concerns regarding the sterility of the devices. These products are intended for the cutting and coagulation of soft tissue.
The recalled products are labeled as "Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length" with reorder number ES0012M. The specific lots affected include 030509-07, 052909-02, 062309-02, 052909-05, and 062309-02. A total of 6,600 units were distributed nationwide, including the state of Illinois.
Healthcare providers and consumers should stop using these specific electrosurgical electrodes immediately. Users should check their inventory for the listed lot numbers and contact Unimed Surgical Products or Medline Industries for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
- Manufacturer
- Unimed Surgical Products, Inc.
- Affected units
- 6,600
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 (2)
- Lot # 052909-05
- 062309-02.
Distribution
Part of a larger recall action
This product is one of 11 recalled by Unimed Surgical Products, 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 11 products in this recall →Related recalls
Same manufacturer · Unimed Surgical Products, Inc.
See all →- ModerateUnimed Recalls Laparoscopic Electrode Hooks Due to Coating Material Changes
FDA (Devices) · 2013-05-29
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighUnimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns
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- HighMedline PTFE Coated Needle Recall Due to Sterility Concerns
FDA (Devices) · 2012-09-05
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