Device recall: Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1…
Class II FDA enforcement event 61982. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Unimed Surgical Products, Inc. started this device recall on 16 Jun 2010. The firm address in the FDA record is in Largo, FL. FDA put the recall in Class II. FDA event 61982 has 11 product records. The first FDA enforcement report date is 5 Sep 2012. The record gives the status Terminated, with the termination date 30 Aug 2012.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution - including the state of IL.
Recalling firm
Unimed Surgical Products, Inc., Largo, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2286-2012 | Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***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.… | 1440 ea | Class II | Terminated | 5 Sep 2012 |
| Z-2287-2012 | 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 of Medline Industries, Inc.… | 240 each | Class II | Terminated | 5 Sep 2012 |
| Z-2288-2012 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***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… | 1440 each | Class II | Terminated | 5 Sep 2012 |
| Z-2289-2012 | 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.… | 3600 each | Class II | Terminated | 5 Sep 2012 |
| Z-2290-2012 | Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81”) Length***Reorder: ESE1651***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.… | 1200 each | Class II | Terminated | 5 Sep 2012 |
| Z-2291-2012 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***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… | 1800 each | Class II | Terminated | 5 Sep 2012 |
| Z-2292-2012 | 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.… | 1920 each | Class II | Terminated | 5 Sep 2012 |
| Z-2293-2012 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0” (10.16cm) Length***Reorder: ES0014AM***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… | 2400 each | Class II | Terminated | 5 Sep 2012 |
| Z-2294-2012 | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***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.… | 1200 each | Class II | Terminated | 5 Sep 2012 |
| Z-2295-2012 | 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 registered trademark of Medline… | 6600 each | Class II | Terminated | 5 Sep 2012 |
| Z-2296-2012 | Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***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… | 3600 each | Class II | Terminated | 5 Sep 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2010
- 37
- Share of these events in Class II
- 89%
- Product records in this event
- 11Median of the firm: 11
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Feb 2013 | PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulat Event 64618 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2286-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 61982. https://recallregister.com/fda/ii/61982/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide Distribution - including the state of IL.
- What quantity of product is in FDA event 61982?
- The event has 11 product records. The first record gives this quantity:
1440 ea
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2010 have the same class?
- 89% of the 37 device events that started in 2010 are in Class II.