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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90304

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

Open FDA event record

Event summary

Timeline bucket
May 09, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton Dickinson & Company

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

11 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 11

BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)

Z-1431-2022
Recall number
Z-1431-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
485,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

UDI: 382903949106 Lot Number/Exp Date: 1154844 5/31/2024 1098945 3/31/2024 1098944 3/31/2024 1098943 3/31/2024 1061533 2/29/2024 1061535 2/29/2024 1061531 2/29/2024 1061526 2/29/2024 1061527 2/29/2024 1061528 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 2 of 11

BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

Z-1432-2022
Recall number
Z-1432-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
2800270

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903946006 Lot Numbers/Exp. Date: 1126369 4/30/2024 1126368 4/30/2024 1152277 5/31/2024 1126371 4/30/2024 1152275 5/31/2024 1126366 4/30/2024 1124513 4/30/2024 1126361 4/30/2024 1214381 7/31/2024 1123653 4/30/2024 1123644 4/30/2024 1098342 3/31/2024 1098335 3/31/2024 1098339 3/31/2024 1085949 2/29/2024 1098333 3/31/2024 1090036 2/29/2024 1085634 2/29/2024 1085635 2/29/2024 1090038 2/29/2024 1090820 2/29/2024 1083414 2/29/2024 1063420 2/29/2024 1063419 2/29/2024 1063417 2/29/2024 1060787 2/29/2024 1060784 2/29/2024 1033322 1/30/2024 1060783 2/29/2024 1060791 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 3 of 11

BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)

Z-1433-2022
Recall number
Z-1433-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
1,960,360

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903946013 Lot Numbers/Exp.Date: 1126398 4/30/2024 1127180 4/30/2024 1127179 4/30/2024 1123685 4/30/2024 1119049 3/31/2024 1126395 4/30/2024 1123679 4/30/2024 1098302 3/31/2024 1123674 4/30/2024 1098301 3/31/2024 1123683 4/30/2024 1123682 4/30/2024 1123670 4/30/2024 1098294 3/31/2024 1098278 3/31/2024 1098283 3/31/2024 1098276 3/31/2024 1090041 2/29/2024 1089729 2/29/2024 1089723 2/29/2024 1098266 3/31/2024 1098272 3/31/2024 1090046 2/29/2024 1090043 2/29/2024 1061602 2/29/2024 1061605 2/29/2024 1033538 1/31/2024 1033511 1/31/2024 1033539 1/31/2024 1033514 1/31/2024 1034769 1/31/2024 1033518 1/31/2024 1034649 1/31/2024 1061584 2/29/2024 1061594 2/29/2024 1061601 2/29/2024 1033510 1/31/2024 1033541 1/31/2024 1033542 1/31/2024 1034656 1/31/2024 1040916 1/31/2024 1061596 2/29/2024 1061598 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 4 of 11

BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

Z-1434-2022
Recall number
Z-1434-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
2,100,210

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903946020 Lot Numbers/Exp.Date: 1152283 5/31/2024 1113643 3/31/2024 1120601 3/31/2024 1113657 3/31/2024 1098327 3/31/2024 1124487 4/30/2024 1098376 3/31/2024 1098372 3/31/2024 1097651 3/31/2024 1098181 3/31/2024 1098379 3/31/2024 1085636 2/29/2024 1085897 2/29/2024 1097647 3/31/2024 1061613 2/29/2024 1063398 2/29/2024 1090040 2/29/2024 1097641 3/31/2024 1097637 3/31/2024 1098371 3/31/2024 1090039 2/29/2024 1085895 2/29/2024 1063392 2/29/2024 1090052 2/29/2024 1061609 2/29/2024 1084430 2/29/2024 1061606 2/29/2024 1063402 2/29/2024 1063369 2/29/2024 1063367 2/29/2024 1063370 2/29/2024 1063390 2/29/2024 1063368 2/29/2024 1063389 2/29/2024 1063366 2/29/2024 1033529 1/31/2024 1040952 1/31/2024 1040913 1/31/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 5 of 11

BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)

Z-1435-2022
Recall number
Z-1435-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903946051 Lot Numbers/Exp.Date: 1133181 4/30/2024 1117434 3/31/2024 1110835 3/31/2024 1119671 3/31/2024 1098353 3/31/2024 1098351 3/31/2024 1098350 3/31/2024 1110839 3/31/2024 1110842 3/31/2024 1067265 2/29/2024 1067268 2/29/2024 1067274 2/29/2024 1063372 2/29/2024 1067273 2/29/2024 1067264 2/29/2024 1034587 1/31/2024 1040899 1/31/2024 1034590 1/31/2024 1034594 1/31/2024 1040902 1/31/2024 1040891 1/31/2024 1034597 1/31/2024 1060806 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 6 of 11

BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)

Z-1436-2022
Recall number
Z-1436-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
54010

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903949007 Lot Numbers/Exp.Date: 1214380 7/31/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 7 of 11

BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)

Z-1437-2022
Recall number
Z-1437-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
9,010

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903949113 Lot Numbers/Exp.Date: 1061512 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 8 of 11

BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)

Z-1438-2022
Recall number
Z-1438-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
448,040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903950003 Lot Numbers/Exp.Date: 1120604 3/31/2024 1098929 3/31/2024 1123643 4/30/2024 1063423 2/29/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 9 of 11

BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)

Z-1439-2022
Recall number
Z-1439-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: N/A Lot Numbers/Exp.Date: 1127328

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 10 of 11

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)

Z-1440-2022
Recall number
Z-1440-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
40,050

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903836871 Lot Numbers/Exp.Date: 1082428 3/31/2024 1097856 3/31/2024 1111860 4/30/2024 1188909 6/30/2024 1208182 7/31/2024 1179403 6/30/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.

device · product 11 of 11

Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)

Z-1441-2022
Recall number
Z-1441-2022
Initiated
May 09, 2022
Classification
Class II
Status
Ongoing
Quantity
44,040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

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

May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

Code information

GTIN: 382903836826 Lot Numbers/Exp.Date: 1082423 3/31/2024 1117627 4/30/2024 1140859 5/31/2024 1210968 7/31/2024

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.