Recall events
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Event 88667
Event summary
Timeline bucket March 10, 2020
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Smiths Medical ASD 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
12 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 12
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Z-0092-2022
Recall number Z-0092-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 17980 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0092-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40409]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35489]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 12
smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
Z-0093-2022
Recall number Z-0093-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 140 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0093-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51745]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35513]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 12
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Z-0094-2022
Recall number Z-0094-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 3100 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0094-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51748]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[32255]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 12
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Z-0095-2022
Recall number Z-0095-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 10620 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0095-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4907]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35499]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 12
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Z-0096-2022
Recall number Z-0096-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 870 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0096-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51749]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34674]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 12
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Z-0097-2022
Recall number Z-0097-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 7080 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0097-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45255]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35502]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 12
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Z-0098-2022
Recall number Z-0098-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 1420 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0098-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26750]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34600]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 12
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Z-0099-2022
Recall number Z-0099-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 20 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0099-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34710]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34841]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 12
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
Z-0100-2022
Recall number Z-0100-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 20800 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0100-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11475]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35325]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0101-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0101-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58344]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[35485]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0102-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 13620 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0102-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11476]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34667]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0103-2022
Initiated March 10, 2020
Classification Class II
Status Terminated
Quantity 3620 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Component design/selection
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0103-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58343]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Code information All codes
Distribution pattern Austria, France, Germany, Great Britain, and Saudi Arabia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34697]
FDA event record
· Exact recall-number query on openFDA
