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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95305

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD 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

9 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 9

CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Z-0010-2025
Recall number
Z-0010-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
125928 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 1061058602228, Lot Numbers: 3977441, 4013370, 3983314, 4013371, 4013369, 4013372, 4025948, 4033993, 4037444, 4040238

Distribution pattern

Worldwide distribution.

device · product 2 of 9

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Z-0011-2025
Recall number
Z-0011-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
385558 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 10610586027239, Lot Numbers: 3971709, 3983317, 3983316, 3983315, 3983318, 3983327, 3983320, 3983321, 3983323, 3983328, 3983322, 4013357, 3983325, 3983324, 3983329, 3983326, 3983330, 3983332, 3983331, 3983334, 4013356, 4034028, 4013355, 4046848, 4013353, 4013358, 3983335, 4013360, 4013361, 4013359, 4013363, 4013362, 4013377, 4013374, 4013376, 4013378, 4013373, 4013375, 4034023, 4019430, 4019427, 4019428, 4034024, 4019429, 4034029, 4037751, 4034026, 4037754, 4037753, 4034031, 4034030, 4034025, 4037757, 4046846, 4037752, 4037756, 4040249, 4037755, 4042843, 4040250, 4040251, 4046845, 4042844, 4046847, 4052411, 4048893, 4066532, 4048892, 4048894, 4052410, 4053920, 4052412, 4052413, 4060911

Distribution pattern

Worldwide distribution.

device · product 3 of 9

CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Z-0012-2025
Recall number
Z-0012-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
26160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 10610586027192, Lot Numbers: 3971732, 3971731, 4034016, 3977457, 4013365, 4019421, 4019422, 4034015, 4037744, 4037745, 4034018, 4034017, 4046844, 4046843, 4053912, 4048899

Distribution pattern

Worldwide distribution.

device · product 4 of 9

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

Z-0013-2025
Recall number
Z-0013-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
119535 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 10610586027215, Lot Numbers: 4042839, 4040248, 4034021, 4052405, 4034022, 4037748, 4042841, 4034019, 4037749, 4040247, 3983339, 3983338, 3983340, 4013367, 4013366, 3988532-ENG, 3983337, 4052406, 4042840, 4052407, 4052408, 4042842, 4048891, 4052409

Distribution pattern

Worldwide distribution.

device · product 5 of 9

CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24

Z-0014-2025
Recall number
Z-0014-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
41964 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 10610586022111, Lot Numbers: 4040237, 4013368, 3983342, 4046817, 405240, 4060903

Distribution pattern

Worldwide distribution.

device · product 6 of 9

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP

Z-0015-2025
Recall number
Z-0015-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
109563 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UID/DI NA, Lot/Serial Numbers: 3983315, 3971709, 3983316, 3983320, 3983329, 4013361, 4013363, 4013373, 4013377, 4013378, 4019427, 4019429, 4034028, 4037753, 4052410, 4040250, 4042843, 4048894, 4046846, 4052412, 4052413

Distribution pattern

Worldwide distribution.

device · product 7 of 9

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP

Z-0016-2025
Recall number
Z-0016-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
8976 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI NA, Lot/Serial Numbers: 4013366, 4034019, 4037749, 4034021, 4040248, 4042841, 4048891, 4052407

Distribution pattern

Worldwide distribution.

device · product 8 of 9

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Z-0017-2025
Recall number
Z-0017-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
2881080 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 4016490AB, 4010570AB, 4010569AB, 4016494AB, 4016497AB, 4010571AB, 4016491AB, 4010572AB, 4010574AB, 4016493AB, 4022630AB, 4025275AB, 4016492AB, 4016495AB, 4022621AB, 4022625AB, 4022628AB, 4006931AB, 4006933AB, 4006930AB, 4006932AB, 4022622AB, 4022623AB, 4022627AB, 4022624AB, 4022626AB, 4022632AB, 4022629AB, 4022631AB, 4025277AB, 4022633AB, 4022634AB, 4025274AB, 4022635AB, 4033938AB, 4033939AB, 4025281AB, 4033937AB, 4025278AB, 4025279AB, 4025280AB, 4033943AB, 4025288AB, 4025282AB, 4025289AB, 4025285AB, 4025286AB, 4025290AB, 4025287AB, 4033934AB, 4033928AB, 4030519AB, 4025291AB, 4025292AB, 4025293AB, 4039970AB, 4039972AB, 4030518AB, 4025295AB, 4039971AB, 4033942AB, 4033927AB, 4033940AB, 4033931AB, 4033930AB, 4033932AB, 4010548AB, 4010551AB, 4033933AB, 4033935AB, 4033936AB, 4039983AB, 4033941AB, 4039973AB, 4039969AB, 4039974AB, 4039987AB, 4039978AB, 4039981AB, 4039975AB, 4039976AB, 4039977AB, 4039979AB, 4039985AB, 4039992AB, 4039988AB, 4039980AB, 4039984AB, 4046424AB, 4039982AB, 4039991AB, 4046419AB, 4039986AB, 4039990AB, 4046422AB, 4039989AB, 4046421AB, 4046423AB, 4046420AB, 4046425AB, 4046430AB, 4046427AB, 4046428AB, 4046426AB, 4046429AB, 4046436AB, 4046431AB, 4058051AB, 4046432AB, 4046437AB, 4046435AB, 4046434AB, 4046433AB, 4046438AB, 4068090, 4071901AB, 4068091, 4068095, 4058044AB, 4058046AB, 4058045AB, 4058047AB, 4058048AB, 4058049AB, 4058050AB, 4058054AB, 4058057AB, 4058062AB, 4058052AB, 4058056AB, 4058063AB, 4058068AB, 4058064AB, 4071892AB, 4071893AB, 4069071AB, 4058066AB, 4071891AB, 4174007AB, 4124420AB, 4146001AB, 4124419AB, 4146000AB, 4147144, 4084056, 4058069AB, 4080944AB, 4058072AB, 4084055, 4058070AB, 4080951AB, 4067648-ENG, 4124438AB, 4124432AB, 4124437AB, 4124439AB, 4146564, 4147141AB, 4174026AB, 4145999AB, 4146002AB, 4147145, 4147143, 4146566, 4146565, 4146567, 4157653AB, 4157654AB, 4158821AB, 4172034, 4163678AB, 4163679AB, 4158820AB, 4163675AB, 4172026AB, 4174012AB, 4174011AB, 4163680AB, 4174016AB, 4174014AB, 4174013AB, 4174643AB, 4174642AB, 4174644AB, 4174641AB, 4174645AB, 4183673AB, 4174646AB, 4174647AB, 4183669AB, 4183007, 4183010, 4183670AB, 4183671AB, 4183672AB, 4183674AB

Distribution pattern

Worldwide distribution.

device · product 9 of 9

ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

Z-0018-2025
Recall number
Z-0018-2025
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
120960 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Code information

UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB

Distribution pattern

Worldwide distribution.