Metal Tray — Class II medical device recall Z-1991-2023
Ongoing recall by Karl Storz Endoscopy, reported 2023-06-28, distributed nationwide. Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) wi
| Recall number | Z-1991-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-06-21 |
| Reported by FDA | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 4,933 |
| UPC / GTIN / UDI-DI | 04048551051801, 04048551051818, 04048551051825, 04048551051832, 04048551157619, 04048551157626, 04048551157657, 04048551157671, 04048551157695, 04048551157756, 04048551157763, 04048551157770, 04048551157879, 04048551241400, 04048551254158, 04048551273432 |
| Model numbers | 11580A, 11580B, 11580C, 11580D, 39501A1, 39501A2, 39501B2, 39501BEC, 39501C, 39501CEC, 39501F, 39501LC2, 39501X, 39501XK, 39501XP, 39550A |
Product
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray Retromolar Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A
Reason for recall
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
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-1991-2023. 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.