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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97317

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

Open FDA event record

Event summary

Timeline bucket
August 06, 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

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

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

Z-2522-2025
Recall number
Z-2522-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
29811 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586022111, Lot Numbers: 6022008, 6022009, 6037749, 6062686, 6062687

Distribution pattern

Worldwide distribution.

device · product 2 of 6

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

Z-2523-2025
Recall number
Z-2523-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
265500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Distribution pattern

Worldwide distribution.

device · product 3 of 6

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24

Z-2524-2025
Recall number
Z-2524-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
289098 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695

Distribution pattern

Worldwide distribution.

device · product 4 of 6

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

Z-2525-2025
Recall number
Z-2525-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
211750 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586027215, Lot Numbers: 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023, 6022024, 6022025, 6022026, 6022028, 6022030, 6022031, 6022032, 6026837, 6026839, 6037765, 6037768, 6037771, 6059294, 6059295, 6059296, 6062697, 6062698, 6077779, 6085509, 6092859, 6101810

Distribution pattern

Worldwide distribution.

device · product 5 of 6

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

Z-2526-2025
Recall number
Z-2526-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
987911 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586027239, Lot Numbers: 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593, 6005601, 6012443, 6012470, 6012472, 6012474, 6012477, 6022033, 6022034, 6022039, 6022040, 6022041, 6022045, 6022046, 6022047, 6022048, 6022049, 6022051, 6022053, 6026851, 6026853, 6026854, 6026855, 6026856, 6026857, 6026858, 6026859, 6026861, 6026862, 6026863, 6026864, 6026865, 6026866, 6026867, 6026868, 6026869, 6026870, 6026872, 6026873, 6026874, 6026875, 6037772, 6037773, 6037774, 6037775, 6037776, 6037777, 6037778, 6037779, 6037780, 6037781, 6037782, 6053814, 6054005, 6054007, 6054008, 6054009, 6054010, 6054011, 6054013, 6054014, 6056238, 6062718, 6054012, 6062712, 6062710, 6062699, 6062714, 6062700, 6062701, 6062702, 6062705, 6062716, 6062703, 6062706, 6062721, 6062711, 6062723, 6062717

Distribution pattern

Worldwide distribution.

device · product 6 of 6

Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product Code 21-7600-24

Z-2527-2025
Recall number
Z-2527-2025
Initiated
August 06, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical Inc.
Quantity
15546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

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

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Code information

UDI/DI 10610586044007, Lot Numbers: 6037784, 6054015

Distribution pattern

Worldwide distribution.