Recall events
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Event 96068
Event summary
Timeline bucket December 13, 2024
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording Trinity Sterile, 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
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
Z-1012-2025
Recall number Z-1012-2025
Initiated December 13, 2024
Classification Class II
Status Ongoing
Quantity 1,980 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for hole in package compromising sterility of the medical kit.
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-1012-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10314]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for hole in package compromising sterility of the medical kit.
Code information Model No IM46062, UDI-DI 10853155008769, Lot Number 600022
Distribution pattern US Nationwide distribution in the states of MD, PA, TN 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[38065]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 5
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Z-1013-2025
Recall number Z-1013-2025
Initiated December 13, 2024
Classification Class II
Status Ongoing
Quantity 1,980 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for hole in package compromising sterility of the medical kit.
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-1013-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57595]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for hole in package compromising sterility of the medical kit.
Code information Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018
Distribution pattern US Nationwide distribution in the states of MD, PA, TN 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[38298]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 5
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
Z-1014-2025
Recall number Z-1014-2025
Initiated December 13, 2024
Classification Class II
Status Ongoing
Quantity 3,960 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for hole in package compromising sterility of the medical kit.
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-1014-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57596]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for hole in package compromising sterility of the medical kit.
Code information Model No DC3080LF, UDI-DI 10857800006872, Lot Number 600022
Distribution pattern US Nationwide distribution in the states of MD, PA, TN 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[3460]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 5
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Z-1015-2025
Recall number Z-1015-2025
Initiated December 13, 2024
Classification Class II
Status Ongoing
Quantity 5,940 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for hole in package compromising sterility of the medical kit.
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-1015-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[28980]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for hole in package compromising sterility of the medical kit.
Code information Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088
Distribution pattern US Nationwide distribution in the states of MD, PA, TN 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[3444]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 5
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Z-1016-2025
Recall number Z-1016-2025
Initiated December 13, 2024
Classification Class II
Status Ongoing
Quantity 280 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for hole in package compromising sterility of the medical kit.
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-1016-2025
Source locator 0001-device-recall-0001-of-0001.json.zip#results[17378]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for hole in package compromising sterility of the medical kit.
Code information Model No TM6180CP, UDI-DI 58500425700020, Lot Number 600032
Distribution pattern US Nationwide distribution in the states of MD, PA, TN 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[38198]
FDA event record
· Exact recall-number query on openFDA
