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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96783

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

Open FDA event record

Event summary

Timeline bucket
May 02, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cardinal Health 200, LLC

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

6 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 6

Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs

Z-1870-2025
Recall number
Z-1870-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
370

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040289; UDI-DI (box) 50192253040287 Lot 2502400146

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

device · product 2 of 6

Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

Z-1871-2025
Recall number
Z-1871-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
1710

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

device · product 3 of 6

Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen

Z-1872-2025
Recall number
Z-1872-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
58742

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040302; UDI-DI (box) 50192253040300 Lots 2431300157 2431300158 2431300156 2431300154 2431300153 2433300197 2431300152 2418100101 2433300200 2418300064 2432300069 2417000115 2431800139 2432200143 2432600251 2417000116 2433300199 2418100103 2432300066 2418300063 2433300195 2432600250 2430300087 2433300193 2430300085 2417000113 2433300201 2432200139 2429900138 2412300004 2430300083 2430300086 2430300084 2418100102 2431300155

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

device · product 4 of 6

Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen

Z-1873-2025
Recall number
Z-1873-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
51378

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

device · product 5 of 6

Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen

Z-1874-2025
Recall number
Z-1874-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
10438

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040364; UDI-DI (box) 50192253040362 Lots 2424900133 2424900134 2424900135 2435200126 2435200127 2435200129 2435200123 2435200124

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

device · product 6 of 6

Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen

Z-1875-2025
Recall number
Z-1875-2025
Initiated
May 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
2280

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Packaging defect
Sterility assurance reason.sterility_assurance · v1.0.0
Packaging defect may compromise sterility of the product. Use of a non-sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information

UDI-DI (ea) 10192253040371; UDI-DI (box) 50192253040379 Lots 2419800006 2335500149

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.