Recall events
/
Event 95261
Event summary
Timeline bucket August 07, 2024
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
19 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 19
PACEMAKER PACK, SLCV01J; Medical convenience kit
Z-3226-2024
Recall number Z-3226-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 20 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3226-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57909]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072213846; Lot: 2405112; Exp: 05/11/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[5075]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 19
Endovascular AAA Pack, ESED52B; Medical convenience kit
Z-3227-2024
Recall number Z-3227-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 93 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3227-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23149]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072218339; Lot: 2405153; Exp: 05/15/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4498]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 19
Endovascular AAA Pack, ESED52B; Medical convenience kit
Z-3228-2024
Recall number Z-3228-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 360 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3228-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17232]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072198402; Lot: 2405152; Exp: 05/15/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4662]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 19
Arthroscopy Pack, MSKA45A; Medical convenience kit
Z-3229-2024
Recall number Z-3229-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 48 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3229-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9903]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072200938; Lot: 2405153; Exp: 05/15/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4890]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 19
Open Shoulder, LWOS39L; Medical convenience kit
Z-3230-2024
Recall number Z-3230-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 12 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3230-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9901]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072177032; Lot: 2405141; Exp: 05/14/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4453]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 19
Day Surgery General Pack, FHGE18T; Medical convenience kit
Z-3231-2024
Recall number Z-3231-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 280 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3231-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[32712]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072210517; Lot: 2405131; Exp: 05/13/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4666]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 19
Shoulder, SESH18I; Medical convenience kit
Z-3232-2024
Recall number Z-3232-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 60 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3232-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57905]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072198532; Lot: 2405112; Exp: 05/11/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[5115]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 19
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Z-3233-2024
Recall number Z-3233-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 18 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3233-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57899]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072178107; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4596]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 19
Paracentesis Thoracente, SLPT76H; Medical convenience kit
Z-3234-2024
Recall number Z-3234-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 504 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3234-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5371]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072199065; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4351]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3235-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3235-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46937]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072184566; Lot: 2405102; Exp: 05/10/2024
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4319]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3236-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3236-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46936]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072201232; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[5080]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3237-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 2 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3237-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51644]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072217660; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4473]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3238-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3238-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5366]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072218841; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4852]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3239-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 1 unit
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3239-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28947]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072206497; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4360]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3240-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 68 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3240-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46938]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072218438; Lot: 2405102; Exp: 05/10/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4658]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3241-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 66 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3241-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28945]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072206244; Lot: 2405092; Exp: 05/09/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4335]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3242-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 57 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3242-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[23144]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072200242; Lot: 2405093; Exp: 05/09/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[5049]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3243-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 36 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3243-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[40726]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072189295; Lot: 2405033; Exp: 05/03/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4653]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-3244-2024
Initiated August 07, 2024
Classification Class II
Status Ongoing
Quantity 3 units
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-3244-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51639]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Code information UDI-DI: 00191072206312; Lot: 2405033; Exp: 05/03/2025
Distribution pattern US Nationwide distribution in the states of MO, MN, MA, OH, NE.
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[4310]
FDA event record
· Exact recall-number query on openFDA
