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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93676

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

Open FDA event record

Event summary

Timeline bucket
December 28, 2023
Product types
Device
Classifications
Class I
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

13 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 13

Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

Z-0847-2024
Recall number
Z-0847-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
20186 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Code information

UDI/DI 26971564466220 (Case), 16971564466223 (Box), 06971564466226 (Each), Lot Numbers: 230503 and 230701

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 2 of 13

Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE

Z-0848-2024
Recall number
Z-0848-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
60760 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Code information

UDI/DI 26971564466237 (Case), 16971564466230 (Box), 06971564466233 (Each), Lot Numbers: 230501, 230502 and 230601

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 3 of 13

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Z-0849-2024
Recall number
Z-0849-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
223056 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Code information

UDI/DI 26971564466244 (Case), 16971564466247 (Box),06971564466240 (Each), Lot Numbers: 230501, 230601 and 230602

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 4 of 13

Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE

Z-0850-2024
Recall number
Z-0850-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
397676 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.

Code information

UDI/DI 26971564466251 (Case), 16971564466254 (Box), 06971564466257 (Each), Lot Numbers: 230501, 230701 and 230702

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 5 of 13

Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777

Z-0851-2024
Recall number
Z-0851-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253034538 (Case), 20192253034537 (Box), 10192253034530 (Each), Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 6 of 13

Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777

Z-0852-2024
Recall number
Z-0852-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253033517 (Case), 20192253033516 (Box), 10192253033519 (Each), Lot Numbers: 230201, 230202, 221201, 221202, 230203, 230204, 230205, 230206, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230207, 230602, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 7 of 13

Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777

Z-0853-2024
Recall number
Z-0853-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253034606 (Case), 20192253034605 (Box), 10192253034608 (Each), Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206, 230207

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 8 of 13

Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T

Z-0854-2024
Recall number
Z-0854-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253025819 (Case), 20192253025818 (Box), 10192253025811 (Each), Lot Numbers: 221101, 221102, 221103, 221104

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 9 of 13

Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777

Z-0855-2024
Recall number
Z-0855-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253034675 (Case), 20192253034674 (Box), 10192253034677 (Each), Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 10 of 13

Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777

Z-0856-2024
Recall number
Z-0856-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253034699 (Case), 20192253034698 (Box), 10192253034691 (Each), Lot Numbers: 221201, 230201, 230601, 230602

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 11 of 13

Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T

Z-0857-2024
Recall number
Z-0857-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 50192253025833 (Case), 20192253025832 (Box), 10192253025835 (Each), Lot Numbers: 221101, 230601

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 12 of 13

Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

Z-0858-2024
Recall number
Z-0858-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 26971564466206 (Case), 16971564466209 (Box), 06971564466202 (Each), Lot Numbers: 230701, 230501

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

device · product 13 of 13

Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE

Z-0859-2024
Recall number
Z-0859-2024
Initiated
December 28, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Code information

UDI/DI 26971564466213 (Case), 16971564466216 (Box), 06971564466219 (Each), Lot Numbers: 230501, 230701, 230601

Distribution pattern

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.