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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98842

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

Open FDA event record

Event summary

Timeline bucket
April 27, 2026
Product types
Device
Classifications
Class I
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

10 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 10

BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.

Z-2248-2026
Recall number
Z-2248-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
990 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405609. UDI Numbers: (10)00382904056094(17)261001(10)B01V212D, (10)00382904056094(17)270101(10)B01V238D. Lot Numbers (Expiration Date): B01V212D (2026-10-01), B01V238D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 2 of 10

BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.

Z-2249-2026
Recall number
Z-2249-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
3,130 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

1. Catalog Number: 405621. UDI Numbers: (01)00382904056216(17)260601(10)B01V142D, (01)00382904056216(17)260628(10)B01V176D. Lot Numbers (Expiration Date): B01V142D (2026-06-01), B01V176D (2026-06-28). 2. Catalog Number: 405735. UDI Numbers: (01)00382904057350(17)260601(10)B01V149D, (01)00382904057350(17)261001(10)B01V190D. Lot Numbers (Expiration Date): B01V149D (2026-06-01), B01V190D (2026-10-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 3 of 10

BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

Z-2250-2026
Recall number
Z-2250-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
890 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405632. UDI Number: (01)00382904056322(17)270101(10)B01V231D; Lot Number (Expiration Date): B01V231D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056322(17)270101(10)B02V248D; Lot Number (Expiration Date): B02V248D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 4 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

Z-2251-2026
Recall number
Z-2251-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
330 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405645. UDI Numbers: (01)00382904056452(17)261001(10)B01V223D. Lot Number (Expiration Date): B01V223D (2026-10-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 5 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

Z-2252-2026
Recall number
Z-2252-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
3,550 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

1. Catalog Numbers: 400868. UDI Numbers: (01)10885403469510(17)261001(10)B01V206D, (01)10885403469510(17)261001(10)B01V220D, (01)10885403469510(17)270101(10)B02V266D. Lot Number (Expiration Date): B01V206D (2026-10-01), B01V220D (2026-10-01), B02V266D (2027-01-01). 2. Catalog Number: 405652. UDI Numbers: (01)00382904056520(17)270130(10)B01V353D, (01)00382904056520(17)270101(10)B02V267D. Lot Numbers (Expiration Date): B01V353D (2027-01-30), B02V267D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 6 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405741.

Z-2253-2026
Recall number
Z-2253-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
290 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405741. UDI Number: (01)00382904057411(17)261001(10)B02V204D. Lot Number (Expiration Date): B02V204D (2026-10-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 7 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405658.

Z-2254-2026
Recall number
Z-2254-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405658. UDI Number: (01)00382904056582(17)261001(10)B01V217D. Lot Number (Expiration Date): B01V217D (2026-10-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 8 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

Z-2255-2026
Recall number
Z-2255-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
13,320 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D (2026-10-01), B01V198D (2026-09-01). 6. Catalog Number: 405709. UDI Numbers: (01)00382904057091(17)261001(10)B02V202D, (01)00382904057091(17)260628(10)B02V174D. Lot Numbers (Expiration Date): B02V202D (2026-10-01), B02V174D (2026-06-28). 7. Catalog Number: 405721. UDI Number: (01)00382904057213(17)270101(10)B02V227D. Lot Number (Expiration Date): B02V227D (2027-01-01). 8. Catalog Number: 405723. UDI Number: (01)00382904057237(17)260628(10)B01V174D, (01)00382904057237(17)270101(10)B02V254D, (01)00382904057237(17)261001(10)B01V189D. Lot Numbers (Expiration Date): B01V174D (2026-06-28), B02V254D (2027-01-01), B01V189D (2026-10-01). 9. Catalog Number: 406704. UDI Number: (01)00382904067045(17)270101(10)B02V246D. Lot Number (Expiration Date): B02V246D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 9 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.

Z-2256-2026
Recall number
Z-2256-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

Catalog Number: 405671. UDI Number: (01)00382904056711(17)270101(10)B01V275D. Lot Number (Expiration Date): B01V275D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056711(17)270101(10)B01V294D; Lot Number (Expiration Date): B01V294D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.

device · product 10 of 10

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.

Z-2257-2026
Recall number
Z-2257-2026
Initiated
April 27, 2026
Classification
Class I
Status
Ongoing
Quantity
5,940 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

Code information

1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D, (01)00382904056377(17)270101(10)B01V241D, (01)00382904056377(17)270101(10)B01V265D, (01)00382904056377(17)261001(10)B02V183D. Lot Numbers (Expiration Date): B01V160D (2026-06-28), B01V241D (2027-01-01), B01V265D (2027-01-01), B02V183D (2026-10-01). 2. Catalog Number: 405707. UDI Number: (01)00382904057077(17)270101(10)B02V230D. Lot Number (Expiration Date): B02V230D (2027-01-01).

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.