CLASS II Device recall · Reported 29 May 2013 · FDA Enforcement Report
Ptfe Coated Disposable Electrosurgical Electrodes recalled
Progressive Medical is recalling Ptfe Coated Disposable Electrosurgical Electrodes -Non-stick Cautery Tip Ptfe Modified, distributed nationwide in the US. The recall was initiated on 12 Apr 2013 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-1356-2013
- FDA event ID
- 64931
- Recalling firm
- Progressive Medical, Fenton, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2013
- FDA classified
- 22 May 2013
- Reported
- 29 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 12 Apr 2013 | Recall initiated by company | |
| 22 May 2013 | Classified by FDA | +40 days |
| 29 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product coatings require 510K approval.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriNebraskaOhioOklahomaOregonTennessee
Questions about this recall
Why was it recalled?
Product coatings require 510K approval.
Which lots are affected?
Lot number 082712-04
Where was it sold?
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 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
16 other products · FDA event 64931This product is part of a recall event; the main page for the event is Ptfe Coated Disposable Electrosurgical Electrodes recalled.
More recalls from Progressive Medical
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ptfe Coated Disposable Electrosurgical Electrodes recalled | Progressive Medical | Other | Nationwide |
| Device | CLASS II | Ptfe Coated Disposable Electrosurgical Electrodes recalled | Progressive Medical | Other | Nationwide |
| Device | CLASS II | Ptfe Coated Disposable Electrosurgical Electrodes recalled | Progressive Medical | Other | Nationwide |
| Device | CLASS II | Ptfe Coated Disposable Electrosurgical Electrodes recalled | Progressive Medical | Other | Nationwide |
| Device | CLASS II | Ptfe Coated Disposable Electrosurgical Electrodes recalled | Progressive Medical | Other | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |