Irrigating Bayonet Forceps 8 — Class II medical device recall Z-1999-2012
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-1999-2012 |
|---|---|
| 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 | 125 units |
| Reason classes | labeling |
| Lot numbers | 023340 |
| Model numbers | 20-0431, 20-0431I, 510 |
| Expiration dates | 2017-02-28 |
Product
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
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-1999-2012. 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.