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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90740

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 22, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Maquet Medical Systems USA

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

4 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 4

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Z-1764-2022
Recall number
Z-1764-2022
Initiated
July 22, 2022
Classification
Class II
Status
Ongoing
Quantity
206 US; 48,960 Worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

Code information

UDI-DI: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681

Distribution pattern

Worldwide distribution - US Nationwide and the countries Canada and Australia.

device · product 2 of 4

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Z-1765-2022
Recall number
Z-1765-2022
Initiated
July 22, 2022
Classification
Class II
Status
Ongoing
Quantity
206 US; 48,960 Worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

Code information

UDI-DI: 04037691773513 Lot 3000183908

Distribution pattern

Worldwide distribution - US Nationwide and the countries Canada and Australia.

device · product 3 of 4

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Z-1766-2022
Recall number
Z-1766-2022
Initiated
July 22, 2022
Classification
Class II
Status
Ongoing
Quantity
6,871 US; 18,670 worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

Code information

UDI-DI: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172

Distribution pattern

Worldwide distribution - US Nationwide and the countries Canada and Australia.

device · product 4 of 4

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

Z-1767-2022
Recall number
Z-1767-2022
Initiated
July 22, 2022
Classification
Class II
Status
Ongoing
Quantity
6,871 US; 18,670 worldwide

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

Code information

UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522

Distribution pattern

Worldwide distribution - US Nationwide and the countries Canada and Australia.