CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Product is labeled in part: "***Medline***Extended Ptfe recalled
Unimed Surgical Products is recalling Product is labeled in part: "***Medline***Extended Ptfe Coated Blade 5 Length***, distributed nationwide in the US. The recall was initiated on 16 Jun 2010 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2292-2012
- FDA event ID
- 61982
- Recalling firm
- Unimed Surgical Products, Largo, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2010
- FDA classified
- 28 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Jun 2010 | Recall initiated by company | |
| 28 Aug 2012 | Classified by FDA | +804 days |
| 5 Sep 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014 -- Lot # 042209-03. Product Usage: Intended for cutting and coagulation of soft tissue.
Where it was distributed
US Nationwide Distribution - including the state of IL.
Questions about this recall
Is Product is labeled in part: "***Medline***Extended Ptfe Coated Blade 5 Length*** recalled?
Yes. Unimed Surgical Products recalled Product is labeled in part: "***Medline***Extended Ptfe Coated Blade 5 Length*** on 16 Jun 2010. The recall is Class II and its status is Terminated. Recall number Z-2292-2012.
Why was it recalled?
On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Which lots are affected?
Lot # 042209-03.
Where was it sold?
US Nationwide Distribution - including the state of IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Unimed Surgical Products
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Progressive Medical Laparoscopic Electrode Ptfe Coated L recalled | Unimed Surgical Products | Other | MO, PA, TN |
| Device | CLASS II | Product is labeled in part: "***Medline***Extended Ptfe recalled | Unimed Surgical Products | Sterility | Nationwide |
| Device | CLASS II | Product is labeled in part: "***Medline***Extended Ptfe recalled | Unimed Surgical Products | Sterility | Nationwide |
| Device | CLASS II | Product is labeled in part: "***Medline***Extended Ptfe recalled | Unimed Surgical Products | Sterility | Nationwide |
| Device | CLASS II | Product is labeled in part: "***Medline***Extended Ptfe recalled | Unimed Surgical Products | Sterility | Nationwide |
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