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SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119...

FDA Device Recall #Z-2664-2020 — Class II — June 19, 2020

Recall Summary

Recall Number Z-2664-2020
Classification Class II — Moderate risk
Date Initiated June 19, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Company
Location Franklin Lakes, NJ
Product Type Devices
Quantity 5,296,132 total

Product Description

SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)

Reason for Recall

Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

Distribution Pattern

Worldwide Distribution

Lot / Code Information

Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439). Lot Numbers: REDT0554 REDW1158 REDW2451 REDX1491 REDY1817 REDY2798 REEN3076 REEP3245 REEP3545 REDR2659 REDS4631 REDT0709 REDT4233 REDU2308 REDV1300 REDV3619 REDX2864 REDY3766 REEP3542 REEQ0644 REER1047 REDX4729 REDZ0700 REDZ1905 REEN1900 REEN2797 REEP3240 REEP4079 REEQ0719 REEQ1251 REER1105 REEQ1250 REDR2870 REDS0199 REDS3479 REDT1592 REDU0734 REDU1349 REDU2234 REDU3360 REDU4418 REDV1066 REDV3684 REDW0388 REDW1159 REDY1595 REDY2936 REDY3545 REDZ1827 REEN2784 REEP0777 REER0610 REER2163 REDS4692 REDT0555 REDU1332 REDU2236 REDV1956 REDW3670 REDX1492 REDX3881 REDX4827 REDY1818 REDY2791 REDY3767 REDZ0388 REDZ1906 REDZ3147 REEN3311 REEQ1172 REER1106 REER2125

Other Recalls from Becton Dickinson & Company

Recall # Classification Product Date
Z-1496-2026 Class II 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... Jan 27, 2026
Z-0504-2026 Class II BD Luer Tip Caps; Catalog Number(s) or Model N... Oct 14, 2025
Z-0736-2024 Class II PosiFlush Prefilled Saline Syringe with General... Nov 16, 2023
Z-0349-2024 Class II BD Alaris Pump infusion sets (Product Name, Cat... Oct 11, 2023
Z-0351-2024 Class II BD Extension Sets (Product Name, Catalog #) ... Oct 11, 2023

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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