Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products 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 concerns for a surgical device) where specific injury or illness 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 triggered by concerns regarding the sterility of the devices. These products are intended for the cutting and coagulation of soft tissue.
The specific items involved are labeled as "MEDLINE Extended PTFE Coated Needle 4.0" (10.16cm) Length, with Reorder code ES0016A. The affected lot number is 121808-20. The recall covers 240 units that were distributed nationwide in the United States, including the state of Illinois.
Consumers and healthcare facilities should stop using the affected electrosurgical electrodes and contact Unimed Surgical Products, Inc. or Medline Industries, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark…
- Manufacturer
- Unimed Surgical Products, Inc.
- Hazard
- Affected units
- 240
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 (1)
- Lot #: 121808-20.
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
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- 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
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
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