Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 7, 2024
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson Infusion Therapy Systems, Inc. recalled BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, … - a moderate-severity action.
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, … was recalled by Becton Dickinson Infusion Therapy Systems, Inc. in August 7, 2024. Reason: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion proce…. Check the official notice for the remedy. Verify recall #Z-2458-2024 with the FDA Devices before acting.
The recall
Becton Dickinson Infusion Therapy Systems, Inc. issued this moderate-severity FDA Devices recall-Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion proce….
- Moderate
- severity level
- 26K units
- affected scope
- Class II
- classification
- August 7, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2458-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2458-2024) was formally reported on August 7, 2024, with the manufacturer initiating the action on June 26, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton Dickinson Infusion Therapy Systems, Inc. is listed as the recalling firm, operating out of Sandy, UT. Federal records list the affected scope as 26,400 units.
The documented reason for this recall is: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. Distribution data in the federal record shows the product reached: US: IL OUS: N/A0. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
26,400 units
Related Recalls
6
3 from same agency
Product description
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Reason for recall
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2458-2024 |
| Date reported | August 7, 2024 |
| Date initiated | June 26, 2024 |
| Recalling firm | Becton Dickinson Infusion Therapy Systems, Inc. |
| Firm location | Sandy, UT |
| Affected scope | 26,400 units |
| Distribution | US: IL OUS: N/A0 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2458-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.. Recalled by Becton Dickinson Infusion Therapy Systems, Inc.. Units affected: 26,400 units.
Why was this product recalled? ▼
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2024. Severity: Moderate. Recall number: Z-2458-2024.
Where was the recalled product distributed? ▼
Distribution: US: IL OUS: N/A0.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2458-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 7, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.