Class I FDA device recall · Z-1507-2025

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

Why it was recalled

Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027);  CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027);  3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026);  CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027);  3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027);  3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027);  CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027);  9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027);  CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025);  3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027);  CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027);  CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027);  3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025);  6174118/00801741139017/REHT2984(1/31/2026);  3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025);  3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025);  2174108/00801741138966/REHU3327(9/30/2025);  9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026);  3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026);  1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025);  CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025);  CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025);  CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026);  1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026);  CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025);  CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025);  9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025);  1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025);  CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025);  3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025);  3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025);  CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025);  1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025);  1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025);  CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025);  CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025);  CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025);  CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025);  CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025);  1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025);  CK000867/00801741163272/REJN2377(5/31/2025);  CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025);  CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025);  CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025);  CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025);  CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025);  CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026);  CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025);  CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025);  CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025);  1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025);  1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025);  1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025);  CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025);  CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025);  CK000411/00801741096303/REJN3872(5/31/2025);  CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025);  1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025);  CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025);  CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025);  CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025);   CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025);  CK000619A/00801741132001/REJN3985(6/30/2025);  CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025);  3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025);  1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025);  9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025);  CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025);  CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026);  CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025);  CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025);  CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025);  CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025);  CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025);  CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026);  CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025);  CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025);  CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025);  CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025);  CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025);  CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025);  CK000266A/00801741185014/REJP2755(7/31/2025);  1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025);  3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025);  CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027);  1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025);  3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025);  CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025);  1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025);  CK000736/00801741139499/REJQ1480(6/30/2025);  CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026);  9194108/00801741028595/REJR0580(9/30/2025);  1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025);  CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025);  CK000609A/00801741222504/REJR1654(6/30/2025);  9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025);  CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025);  CK000077D/00801741139598/REJR2231(9/30/2025);  CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025);  CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025);  CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025);  CK000870A/00801741184246/REJS3569(10/31/2025);  CK000443C/00801741226557/REJT0880(10/31/2025);  CK000668B/00801741228674/REJT1820(10/31/2025);  CK000784/00801741189012/REJU0379(9/30/2025)

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Recall record

Recalling firm: Bard Access Systems, Inc.
Product type: Devices
Recall number: Z-1507-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Salt Lake City, UT
Recall initiated: 2025-03-11

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1507-2025 · Source: openFDA enforcement.