# FDA recall Z-1810-2022

> **Unomedical A/S** · Class II · device recall initiated 2022-07-21.

## Product

Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824.  Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

## Reason for recall

The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.

## Distribution

Distribution was made to California.  There was no government/military distribution.

## Key facts

- **Recall number:** Z-1810-2022
- **Recalling firm:** Unomedical A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-21
- **Report date:** 2022-10-05
- **Termination date:** 2026-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** LEJRE, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1810-2022

## Citation

> AI Analytics. FDA recall Z-1810-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1810-2022. Source: US FDA. Licensed CC0.

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