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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90719

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 21, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Unomedical A/S

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1810-2022
Recall number
Z-1810-2022
Initiated
July 21, 2022
Classification
Class II
Status
Terminated
Recalling firm
Unomedical A/S
Quantity
1,643,320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

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

Field note

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