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FDA DevicesClass II

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Published: May 27, 2026Recall ID: Z-2203-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Recalling Firm: Becton, Dickinson and Company

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Reason for Recall / Hazard

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

Product Description & Identification

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Additional Source Details

FieldValue
CityIrvine
StateCA
Event id98603
Address 117200 Laguna Canyon Rd
Code infoModel-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371
Postal code92618-5403
Report date20260527
Product typeDevices
Product quantity183
Reason for recallCatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260408
Center classification date20260515

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmBecton, Dickinson and Company
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Becton, Dickinson and Company - Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

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https://therecallfile.com/recalls/swan-ganz-jr-catheter-models-sgpt54-sgpt64p-sgpt755p/FDA-Z-2203-2026
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