Recall events
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Event 89868
Event summary
Timeline bucket March 22, 2022
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording American Contract Systems, 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
5 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 5
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Z-1036-2022
Recall number Z-1036-2022
Initiated March 22, 2022
Classification Class II
Status Ongoing
Quantity 72 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product was sterilized with a higher than specification EO concentration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1036-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4478]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Product was sterilized with a higher than specification EO concentration.
Code information 1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
Distribution pattern US Nationwide distribution in the states of IL, MO, NE, and TX.
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[35745]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Z-1037-2022
Recall number Z-1037-2022
Initiated March 22, 2022
Classification Class II
Status Ongoing
Quantity 114 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product was sterilized with a higher than specification EO concentration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1037-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26870]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Product was sterilized with a higher than specification EO concentration.
Code information 1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954
Distribution pattern US Nationwide distribution in the states of IL, MO, NE, and TX.
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[35631]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
ACS IR - Angio Pack
Z-1038-2022
Recall number Z-1038-2022
Initiated March 22, 2022
Classification Class II
Status Ongoing
Quantity 24 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product was sterilized with a higher than specification EO concentration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1038-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58595]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Product was sterilized with a higher than specification EO concentration.
Code information Model JEIR37H, Lot 657211 UDI: 00191072151612
Distribution pattern US Nationwide distribution in the states of IL, MO, NE, and TX.
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[33412]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
ACS Lap Chole Pack
Z-1039-2022
Recall number Z-1039-2022
Initiated March 22, 2022
Classification Class II
Status Ongoing
Quantity 20 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product was sterilized with a higher than specification EO concentration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1039-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45373]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Product was sterilized with a higher than specification EO concentration.
Code information Model BLLC42M, Lot 643211 UDI: 00191072152473
Distribution pattern US Nationwide distribution in the states of IL, MO, NE, and TX.
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[33863]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
ACS Cath Lab Pack
Z-1040-2022
Recall number Z-1040-2022
Initiated March 22, 2022
Classification Class II
Status Ongoing
Quantity 10 packs
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Product was sterilized with a higher than specification EO concentration.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1040-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9420]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Product was sterilized with a higher than specification EO concentration.
Code information Model FTCL83K, Lot 982221 UDI: 00191072151360
Distribution pattern US Nationwide distribution in the states of IL, MO, NE, and TX.
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[33395]
FDA event record
· Exact recall-number query on openFDA
