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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97583

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

Open FDA event record

Event summary

Timeline bucket
September 08, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ICU 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

38 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 38

ChemoLock Bag Spike, 01 units REF: CL-10-10

Z-0328-2026
Recall number
Z-0328-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
875 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709071022/Lot: 14397202

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 2 of 38

ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

Z-0329-2026
Recall number
Z-0329-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
2100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:00887709070981/Lot: 14380109

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 3 of 38

ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

Z-0330-2026
Recall number
Z-0330-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
2000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:00887709094505/Lot: 14407400

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 4 of 38

ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

Z-0331-2026
Recall number
Z-0331-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709094670/Lot: 14391937

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 5 of 38

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011

Z-0332-2026
Recall number
Z-0332-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
11000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709057019/Lot: 14386054

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 6 of 38

ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

Z-0333-2026
Recall number
Z-0333-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
7950 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709057026/Lot: 14400616

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 7 of 38

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929

Z-0334-2026
Recall number
Z-0334-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
1100 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709076768/Lot: 14400216, 14416769

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 8 of 38

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

Z-0335-2026
Recall number
Z-0335-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
3000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709095295/Lot: 14406773

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 9 of 38

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

Z-0336-2026
Recall number
Z-0336-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709096131/Lot: 14393176

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 10 of 38

ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

Z-0337-2026
Recall number
Z-0337-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709096131/Lot: 14393176

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 11 of 38

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

Z-0338-2026
Recall number
Z-0338-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
950 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709098388/Lot: 14400230

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 12 of 38

ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

Z-0339-2026
Recall number
Z-0339-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709123080/Lot: 14351926

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 13 of 38

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

Z-0340-2026
Recall number
Z-0340-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709123356/Lot: 14332784

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 14 of 38

ICU Medical ChemoLock Bag Spike REF: CL-10

Z-0341-2026
Recall number
Z-0341-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
7850 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709056968/Lot: 14419330

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 15 of 38

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

Z-0342-2026
Recall number
Z-0342-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
4000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10840619061729/Lot: 14393155, 14400613, 14376051

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 16 of 38

ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

Z-0343-2026
Recall number
Z-0343-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
16850 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709057095/Lot: 14391971, 14395289

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 17 of 38

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

Z-0344-2026
Recall number
Z-0344-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
11200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709067155/Lot:14379176

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 18 of 38

ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

Z-0345-2026
Recall number
Z-0345-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
9004 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709062440/Lot:14385352, 14401250

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 19 of 38

ICU Medical ChemoLock Closed Vial Spike REF: CL-80

Z-0346-2026
Recall number
Z-0346-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
6150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709057125/Lot:14391976

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 20 of 38

ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

Z-0347-2026
Recall number
Z-0347-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
53,050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709069593/Lot:14379182, 14391979, 14395300, 14401254, 14380121

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 21 of 38

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

Z-0348-2026
Recall number
Z-0348-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
8475 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709077116/Lot:14395313, 14393195, 14396054

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 22 of 38

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

Z-0349-2026
Recall number
Z-0349-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
3350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709085692/Lot:14407453

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 23 of 38

ICU Medical ChemoLock Port REF: CL2100

Z-0350-2026
Recall number
Z-0350-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
133,255 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709057002/Lot:14400191, 14379145

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 24 of 38

ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

Z-0351-2026
Recall number
Z-0351-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
950 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709071398/Lot:14397348, 14377757

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 25 of 38

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

Z-0352-2026
Recall number
Z-0352-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
1700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709071411/Lot:14391954

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 26 of 38

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

Z-0353-2026
Recall number
Z-0353-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
6450 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

UDI:10887709071411/Lot:14386086 14407433

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 27 of 38

ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

Z-0354-2026
Recall number
Z-0354-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14401659/ Distributed in France

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 28 of 38

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

Z-0355-2026
Recall number
Z-0355-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14385224; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 29 of 38

ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

Z-0356-2026
Recall number
Z-0356-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14400199; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 30 of 38

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

Z-0357-2026
Recall number
Z-0357-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
2000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14407070,14384996,14391949; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 31 of 38

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

Z-0358-2026
Recall number
Z-0358-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
2450 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14393168, 14414091; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 32 of 38

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

Z-0359-2026
Recall number
Z-0359-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
11000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14397353, 14418912; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 33 of 38

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

Z-0360-2026
Recall number
Z-0360-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
5700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14369083 14386090 14391965; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 34 of 38

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

Z-0361-2026
Recall number
Z-0361-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
1600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14393173, 14409213 ; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 35 of 38

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

Z-0362-2026
Recall number
Z-0362-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14369087 ; Distributed in Canada

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 36 of 38

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

Z-0363-2026
Recall number
Z-0363-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
134700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 37 of 38

ICU Medical ChemosafeLock Connecter REF: KL-FNU3

Z-0364-2026
Recall number
Z-0364-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
134,700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

device · product 38 of 38

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

Z-0365-2026
Recall number
Z-0365-2026
Initiated
September 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
202900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Code information

Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; Distributed in Japan

Distribution pattern

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.