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Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Ch...

FDA Device Recall #Z-1970-2025 — Class II — May 12, 2025

Recall Summary

Recall Number Z-1970-2025
Classification Class II — Moderate risk
Date Initiated May 12, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm BD SWITZERLAND SARL
Location Eysins
Product Type Devices
Quantity 2,024,780

Product Description

Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

Reason for Recall

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.

Lot / Code Information

REF/UDI-DI/Lot(Expiration): 10013361T/10885403223204/23025303(February 10, 2026), 23035235(March 11, 2026), 23045223(April 6, 2026), 23075395(July 17, 2026), 23085227(August 8, 2026), 23115150(November 8, 2026), 23115151(November 8, 2026), 23125167(December 5, 2026), 24025684(February 6, 2027), 24045377(April 23, 2027), 24055576(May 27, 2027), 24075224(July 26, 2027), 24105079(October 11, 2027), 24115159(November 7, 2027); 10321213T/10885403228971/23035169(March 15, 2026), 23045174(April 4, 2026), 23085140(August 3, 2026), 23095142(September 11, 2026), 23105297(October 12, 2026), 24025686(February 6, 2027); 22000-B007T/10885403245022/23025320(February 13, 2026), 23045224(April 11, 2026), 23065209(June 10, 2026), 23075394(July 21, 2026), 23095143(September 11, 2026), 23105133(October 6, 2026), 24015278(January 13, 2027), 24025685(February 6, 2027), 24036209(March 25, 2027), 24075260(July 26, 2027), 24066653(June 24, 2027); 22600-0007T/10885403239595/23095151(September 11, 2026), 24036205(March 25, 2027), 24055601(May 27, 2027); 22602-B007T/10885403240935/23045501(April 20, 2026), 23095152(September 11, 2026), 24015186(January 9, 2027), 24026152(February 27, 2027), 24036206(March 25, 2027), 24045384(April 23, 2027), 24115032(November 2, 2027); 22603-B007T/10885403240942/23035482(March 23, 2026), 23035504(March 25, 2026), 23055379(May 23, 2026), 23065210(June 12, 2026), 23075056(July 13, 2026), 23085141(August 3, 2026), 23095808(September 14, 2026), 23105296(October 12, 2026), 23125107(December 4, 2026), 24015185(January 9, 2027), 24025681(February 6, 2027), 24026153(February 27, 2027), 24026154(February 27, 2027), 24036207(March 25, 2027), 24045381(April 23, 2027), 24055577(May 27, 2027), 24066654(June 24, 2027), 24085243(August 26, 2027), 24095223(September 23, 2027), 24115312(December 2, 2027); 24010-0007T/10885403271021/23025108(February 8, 2026), 23035249(March 14, 2026), 23075392(July 18, 2026), 23085223(August 8, 2026), 23095763(September 19, 2026), 23105136(October 6, 2026), 23115054(November 3, 2026), 24015279(January 13, 2027), 24015386(January 17, 2027), 24025683(February 6, 2027), 24026149(February 27, 2027), 24045382(April 23, 2027), 24055598(May 27, 2027), 24075225(July 26, 2027), 24085240(August 26, 2027), 24095220(September 23, 2027), 24115311(November 14, 2027), 24066656(June 24, 2027); 24301-0007T/10885403223198/23025183(February 9, 2026), 23025238(February 10, 2026), 23035338(March 16, 2026), 23045222(April 12, 2026), 23075393(July 20, 2026), 23085226(August 8, 2026), 23095764(September 19, 2026), 23105284(October 11, 2026), 23115055(November 3, 2026), 24026089(February 21, 2027), 24026150(February 27, 2027), 24036178(March 25, 2027), 24045383(April 23, 2027), 24055599(May 27, 2027), 24075212(July 26, 2027), 24085241(August 26, 2027), 24095221(September 23, 2027), 24115279(November 12, 2027), 24015474(January 20, 2027); 24601-B007T/10885403240959/23035170(March 9, 2026), 23055380(May 24, 2026), 23065280(June 13, 2026), 23085142(August 3, 2026), 23095153(September 11, 2026), 23105285(October 11, 2026), 23115052(November 3, 2026), 24025682(February 6, 2027), 24026151(February 27, 2027), 24036208(March 25, 2027), 24055600(May 27, 2027), 24075261(July 26, 2027), 24085242(August 26, 2027), 24105106(October 22, 2027), 24066655(June 24, 2027), 24015475(January 20, 2027); 70001B-07T/10885403240997/24109019(October 2, 2027), 24109018(October 2, 2027), 24089215(August 9, 2027), 24089214(August 9, 2027), 24019266(January 16, 2027), 23109293(October 23, 2026), 24099179(September 5, 2027), 24049266(April 15, 2027), 24039248(March 14, 2027); 20350ET/10885403229756/24129026(November 13, 2027), 24079037(July 2, 2027), 24059361(May 15, 2027), 25029088(February 4, 2028), 24049028(April 2, 2027); 40000-07T/10885403225628/24119116(November 6, 2027), 24089019(August 1, 2027), 24079173(July 3, 2027), 24059480(May 28, 2027), 24059152(May 7, 2027), 24019267(January 16, 2027), 23119354(November 29, 2026), 24049267(April 15, 2027), 24039212(March 12, 2027), 23109275(October 19, 2026), 23079215(July 20, 2026); 10013364T/10885403198915/24109021(October 2, 2027), 24109020(October 2, 2027), 24099172(September 5, 2027), 24089059(August 5, 2027), 24089058(August 4, 2027), 24079175(July 3, 2027), 24079174(July 3, 2027), 24059506(May 30, 2027), 24059469(May 28, 2027), 24059151(May 7, 2027), 24039059(March 4, 2027), 24019435(January 31, 2027), 24019268(January 16, 2027), 24019433(January 30, 2027), 24019269(January 16, 2027), 23119087(November 6, 2026), 23129229(December 13, 2026), 23129230(December 13, 2026), 23059178(May 24, 2026), 23059177(May 23, 2026), 23059156(May 16, 2026), 23049061(April 26, 2026), 24059150(May 7, 2027), 24049265(April 15, 2027), 23109175(October 13, 2026), 23109006(October 2, 2026), 23099219(September 12, 2026), 23099217(September 11, 2026), 23059179(May 29, 2026); 4030B-07T/10885403240867/24089216(August 9, 2027), 24059484(May 28, 2027), 24039060(March 4, 2027), 25029393(February 27, 2028), 23109296(October 23, 2026); 22005E-07T/10885403250781/23029335(February 24, 2026)

Other Recalls from BD SWITZERLAND SARL

Recall # Classification Product Date
Z-2453-2025 Class II BD PhaSeal Injector Luer (N30C), REF: 515001 B... Jun 16, 2025
Z-1973-2025 Class II BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... May 12, 2025
Z-1971-2025 Class II BD Texium Needle-Free Syringe: 3 mL, REF: MY800... May 12, 2025
Z-1974-2025 Class II BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... May 12, 2025
Z-1972-2025 Class II BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: M... May 12, 2025

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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