# FDA recall Z-1641-2021

> **BIOPSYBELL S.R.L.** · Class II · device recall initiated 2021-03-22.

## Product

11G DIRECT SINGLE - DELIVERY  (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK

## Reason for recall

Products labeled as sterile were distributed, but may not have been sterilized.

## Distribution

US Nationwide distribution in the states MS and KY.

## Key facts

- **Recall number:** Z-1641-2021
- **Recalling firm:** BIOPSYBELL S.R.L.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-22
- **Report date:** 2021-05-26
- **Termination date:** 2026-02-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mirandola, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2021

## Citation

> AI Analytics. FDA recall Z-1641-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1641-2021. Source: US FDA. Licensed CC0.

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