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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98552

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2026
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
B Braun Medical Inc

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

6 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 6

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

Z-1798-2026
Recall number
Z-1798-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
3,158,104 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number SL-2010M2096A; UDI-DI Primary: 04046955674992; UDI-DI Unit: 04046955735280; All lots manufactured since 09JUN2025

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 6

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Z-1799-2026
Recall number
Z-1799-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
2,653,711 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 3 of 6

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

Z-1800-2026
Recall number
Z-1800-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
1,174,271 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number: SL-2000M2095DA; UDI-DI Primary: 04046955776023; UDI-DI Unit: 04046955776016; All lots manufactured since 09JUN2025.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 4 of 6

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

Z-1801-2026
Recall number
Z-1801-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
328,640 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number: SL-2000M2095L; UDI-DI Primary: 04046955348909; UDI-DI Unit: 04046955348893; All lots manufactured since 29JUN2025.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 5 of 6

B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

Z-1802-2026
Recall number
Z-1802-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
4,848 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number: B3-3632M3705; UDI-DI Primary: 04046955348824; UDI-DI Unit: 04046955348817; All lots manufactured since 01AUG2025.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 6 of 6

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

Z-1803-2026
Recall number
Z-1803-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
4,884 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Code information

Model Number: B3-4630M4705; UDI-DI Primary: 04046955348848; UDI-DI Unit: 04046955348831; All lots manufactured since 05AUG2025.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.