Bayonet Forceps 8 — Class II medical device recall Z-1997-2012
Terminated recall by PSC Industries Inc, reported 2012-07-18, distributed nationwide. Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the let
| Recall number | Z-1997-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PSC Industries Inc, Louisville, KY, United States |
| Recall initiated | 2012-06-01 |
| Classified | 2012-07-11 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PH |
| Quantity | 10 units |
| Reason classes | labeling |
| Lot numbers | 023340 |
| Model numbers | 20-11420, 20-13420, 510 |
| Expiration dates | 2017-02-28 |
Product
Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures
Reason for recall
Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel pouch, the letter 'E' in Electrosurgical was turned into an 'X' and the number '5" of the (mm tips) was turned into a '0'. This affected the description and some of the text of the labels. However, it did not t affect the Part Number and Lot Number on the label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1997-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.