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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91350

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

Open FDA event record

Event summary

Timeline bucket
December 15, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stradis Healthcare

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

18 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 18

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Z-0931-2023
Recall number
Z-0931-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
920 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 2 of 18

PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

Z-0932-2023
Recall number
Z-0932-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number 477944, UDI-DI: M7524779441, Lot Numbers: 220974270, 220915145

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 3 of 18

Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.

Z-0933-2023
Recall number
Z-0933-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
1,040 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 4 of 18

Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;

Z-0934-2023
Recall number
Z-0934-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
21,755 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161. a. Assembly Number 570-1159, UDI-DI: H65857011591, Lot Numbers: 221668682, 222501598, 222308841, 222521158, 222238329, 222276824, 221053079, 221872664; b. Assembly Number 570-1160, UDI-DI: H65857011601, Lot Numbers: 222521156, 222429019, 222428991, 220452660, 222439059, 222428995, 221055116, 222288188, 222501154, 222501155, 222521157, 220762521, 222509319, 222769004, 222639005, 220141429, 222508994; c. Assembly Number 570-1161, UDI-DI: H65857011611, Lot Numbers: 220692475, 222308200, 220251830, 220954105, 220962657, 222248185, 220250698, 222298349, 220251993, 222308198, 222298840, 222521804, 220963077, 220986550, 220141428; d. Assembly Number 570-1162, UDI-DI: H65857011621, Lot Numbers: 221196021, 220462656, 221056018, 221056532, 222308350, 221176016, 221054106, 221056019, 222308552, 222501299, 222501300, 222521301, 220973076, 220896020, 221026017, 213631427; e. Assembly Number 570-1164, UDI-DI: H65857011641, Lot Numbers: 222016037, 222358186, 222430336, 221946035, 222439014, 222430367, 222630366, 222902499, 220252640, 222496579, 221053074, 222350340, 222016033, 222016036, 222146031, 222358129, 222358550, 222496823, 222691515, 220462661, 222692162, 222016034, 222509320, 222692160, 221956029, 220452523, 222016032, 222499000; f. Assembly Number 570-1163, UDI-DI: H65857011631, Lot Numbers: 222290711, 221796024, 221796026, 221796027, 222497161, 222509729, 222510199, 221193075, 222458997, 221024107, 221796025, 222509511, 221796023, 221796022

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 5 of 18

PICC KIT, 10/CS, ACCESS MEDICAL LABEL

Z-0935-2023
Recall number
Z-0935-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
180 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number ACC-2550, UDI-DI: M752ACC25501, Lot Number: 220241506

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 6 of 18

HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Z-0936-2023
Recall number
Z-0936-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
644 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT10500, UDI-DI: M752HCT105002, Lot Number: 220602531

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 7 of 18

HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Z-0937-2023
Recall number
Z-0937-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
2,779 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 8 of 18

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Z-0938-2023
Recall number
Z-0938-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
112,675 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 9 of 18

HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Z-0939-2023
Recall number
Z-0939-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
76,260 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT3916-1, UDI-DI: M752HCT391611, Lot Numbers: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, 221458554

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 10 of 18

HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology

Z-0940-2023
Recall number
Z-0940-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
1,176 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT8249CP-3, UDI-DI: M752HCT8249CP30, Lot Numbers: 222098152, 222551621, 221010141, 222309118, 222901807

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 11 of 18

HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Z-0941-2023
Recall number
Z-0941-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
200 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 12 of 18

Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group

Z-0942-2023
Recall number
Z-0942-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
2,500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number MAG-3000, UDI-DI: M752MAG30001, Lot Numbers: 220883387, 221226000, 220960490, 220986568, 222074682, 222458932

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 13 of 18

McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

Z-0943-2023
Recall number
Z-0943-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
250 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number MC-3535PT, UDI-DI: M752MC3535PT1, Lot Numbers: 220673037, 222096813

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 14 of 18

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Z-0944-2023
Recall number
Z-0944-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
80 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number TCTR01, UDI-DI: M752TCTR011, Lot Numbers: 222014334

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 15 of 18

Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Z-0945-2023
Recall number
Z-0945-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
1,175 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 16 of 18

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Z-0946-2023
Recall number
Z-0946-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
275 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 17 of 18

Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.

Z-0947-2023
Recall number
Z-0947-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
600 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number TM8823-1, UDI-DI: M752TM882310, Lot Number: 220110674

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

device · product 18 of 18

Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

Z-0948-2023
Recall number
Z-0948-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Stradis Healthcare
Quantity
200 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach
Sterility assurance reason.sterility_assurance · v1.0.0
bag having pinhole leaks near the seal, which may result in a breach in the sterility

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Code information

Assembly Number VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083

Distribution pattern

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.