CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Product is labeled in part: "***Medline***Standard Ptfe recalled
Unimed Surgical Products is recalling Product is labeled in part: "***Medline***Standard Ptfe Coated Needle 2.75" 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-2289-2012
- 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
- Syringes & Needles
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***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***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 # ES0013 -- Lot # 030309-02 and 030509-05 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
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 # 030309-02 and 030509-05
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 61982More 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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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |