---
title: "Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... — FDA record Z-1810-2022 | Is It on Recall"
description: "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."
url: https://isitonrecall.com/recall/fda-device-z-1810-2022-autosoft-90-model-numbers-1000282-1002817-1002818-1002819-1002820-1002821-1002822-1002823-and-100282/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infus... — FDA record Z-1810-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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.
- **Classification**: Class II
- **Recalling firm**: Unomedical A/S
- **Quantity**: 1,643,320 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1810-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1810-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 05705244018129. Model 1000282, lot numbers: 5381154 and 5381155; Model 1002817, lot numbers: 5372743, 5381082, 5381087, 5381083, 5381088, 5381091, 5381159, 5381084, 5381089, 5381160, 5381092, 5381094, 5381156, 5381157, 5381090, 5381158, 5372745, 5381085, 5381093, 5381086, 5381101,5372744, 5381095, 5381096, 5381097, 5381099, 5381098, 5381100, 5381162, 5381107, 5381103, 5381102, 5381104, 5381108, 5381164, 5381105, 5381109, 5381161, 5381163, 5381166, 5381106, 5381165, 5381169, 5381168, 5381172, 5381167, 5381170, 5381171, 5381173, 5381178, 5381175, 5381179, 5381180, 5381176, 5381174, 5381177, 5381181, 5381182, 5381183, 5381184, 5381186, 5381189, 5381197, 5381190, 5381192, and 5381194; Model 1002818, lot numbers: 5381110, 5381111, 5381112, 5381113, and 5381200; Model 1002819, lot numbers: 5372758, 5381114, 5372759, 5381115, 5372756, 5381117, 5381118, 5381121, 5381116, 5381120, 5381122, 5381205, 5381208, 5381202, 5381119, 5381204, 5381203, 5381207, 5381206, and 5381209. Model 1002820, lot numbers: 5372762, 5381123, 5381124, 5383835, 5381125, and 5381215; Model 1002821, lot numbers: 5381126, 5381127, 5381128, 5381129, 5381130, 5381133, 5381134, 5381132, 5381131, 5381218, 5381223, 5381219, 5381221, 5381220, 5381222, and 5381224; Model 1002822, lot numbers: 5381135, 5381136, and 5381228. Model 1002823, lot numbers: 5381139, 5381137, 5381138, 5381140, 5381141, 5381142, 5381144, 5381145, 5381146, 5381147, 5381143, 5381148, 5381149, 5381230, 5381229, 5381232, 5381231, 5381233, 5381234, 5381235, and 5381238; and Model, 1002824, lot numbers: 5376469 and 5381243. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)

## Dates in the source

- **Report date**: Oct 5, 2022
- **Recall initiation date**: Jul 21, 2022
- **Center classification date**: Sep 26, 2022
- **Termination date**: May 4, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1810-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Unomedical A/S records](https://isitonrecall.com/brand/unomedical-a-s/)