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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96865

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

Open FDA event record

Event summary

Timeline bucket
May 21, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton Dickinson Infusion Therapy Systems, 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

REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY

Z-1999-2025
Recall number
Z-1999-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot # 4229661/UDI: 382903814237

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 2 of 9

REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly

Z-2000-2025
Recall number
Z-2000-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot: 4222721/ UDI: 382903826339

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 3 of 9

REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly

Z-2001-2025
Recall number
Z-2001-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot # 4282452/UDI: 382903815333

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 4 of 9

REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly

Z-2002-2025
Recall number
Z-2002-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot # 4290664/UDI:382903814336

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 5 of 9

REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Z-2003-2025
Recall number
Z-2003-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot# 4298108/UDI:382903829446

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 6 of 9

REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Z-2004-2025
Recall number
Z-2004-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot# 4208538/UDI: 00382903818112

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 7 of 9

REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Z-2005-2025
Recall number
Z-2005-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot# 4312025 UDI: 00382903825448

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 8 of 9

REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

Z-2006-2025
Recall number
Z-2006-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot# 4282308/UDI: 382903819232

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

device · product 9 of 9

REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly

Z-2007-2025
Recall number
Z-2007-2025
Initiated
May 21, 2025
Classification
Class II
Status
Ongoing
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

Code information

Lot# 4116814/ UDI: 00382903814343

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.