Device recall: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated…
Class II FDA enforcement event 64931. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product coatings require 510K approval.
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
Progressive Medical Inc started this device recall on 12 Apr 2013. The firm address in the FDA record is in Fenton, MO. FDA put the recall in Class II. FDA event 64931 has 17 product records. The first FDA enforcement report date is 29 May 2013. The record gives the status Terminated, with the termination date 7 May 2014.
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.
Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
Recalling firm
Progressive Medical Inc, Fenton, MO.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1348-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 28 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1349-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 19 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1350-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 173 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1351-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 150 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1352-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 59 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1353-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 20 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1354-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 20 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1355-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 38 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1356-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 27 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1357-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 16 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1358-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 60 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1359-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 20 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1360-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 19 boxes with 6 units each. | Class II | Terminated | 29 May 2013 |
| Z-1361-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 39 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1362-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 18 boxes with 12 units each. | Class II | Terminated | 29 May 2013 |
| Z-1363-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries | 4 boxes containing 6 individually packaged pieces each | Class II | Terminated | 29 May 2013 |
| Z-1364-2013 | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries | 11 boxes with 25 units each. | Class II | Terminated | 29 May 2013 |
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 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 17Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Dec 2011 | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in | Device | Class II | 1 |
| 28 Oct 2011 | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1348-2013The 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 64931. https://recallregister.com/fda/ii/64931/. 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:
Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
- What quantity of product is in FDA event 64931?
- The event has 17 product records. The first record gives this quantity:
28 boxes with 12 units each.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.