Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X ...
FDA Device Recall #Z-2394-2026 - Class I, April 21, 2026
Recall Summary
| Recall Number | Z-2394-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | April 21, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ARROW INTERNATIONAL, LLC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 177,014 |
Product Description
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L
Reason for Recall
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Distribution Pattern
US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Lot / Code Information
REF(Material)/UDI-DI/Lot(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25J0198, 33F26B0228, 33F26B0831, 33F26C0534; CDC-34041-VPS/10801902193275/33F24L0236; CDC-35052-VPS/10801902193275/33F25E0425; ASK-04001-BWK2/10801902193275/33F25A0226, 33F25D0389, 33F25E0519, 33F25F0076, 33F25F0139, 33F25H0660, 33F25J0347, 33F26A1341; ASK-04001-DU11/10801902193275/33F25C0425, 33F25D0328, 33F25F0140, 33F25H0506; ASK-42703-PVD/10801902156966, 10801902193275/33F24F0977, 33F24L1004, 33F25C0302, 33F25K0144, 33F26B0157; ASK-12703-LMDTG1/10801902193275, 10801902205688/33F25D0262, 33F25G0280, 33F26B0212; ASK-15703-ECMC4/10801902159950, 10801902193275/33F24E0649, 33F24F1039, 33F25B0439; ASK-15703-PNM/10801902193275/33F25E0312; ASK-22123-UAB/10801902144956, 10801902193275/33F24F0854, 33F24L0318, 33F25C0281, 33F25D0267, 33F25D0593, 33F25J0380; CDC-24402-X1A/10801902193275, 10801902168099/33F24L1111, 33F25C0206, 33F25E0747, 33F25G0341, 33F25H0554, 33F25J0324, 33F26A1561, 33F26B0165, 33F26B0803; CDC-25123-X1A/10801902193275, 10801902168105/33F25B0675, 33F25D0501, 33F25E0887, 33F25G0379, 33F26A1562, 33F26B0892; ASK-42703-CPR/10801902193275, 10801902135220/33F25C0744, 33F25E0234, 33F25J0559, 33F25J0797, 33F25K0401, 33F26B0244; ASK-42802-DMC2/10801902193275/33F25E0005; ASK-45802-PCMH1/10801902193275/33F25D0034; ASK-42703-MM1/10801902193275, 10801902221916/33F25E0509, 33F25E0559, 33F25M0205, 33F25M0449, 33F26A1659, 33F26B0196; ASK-42703-PHUMC1/10801902193275/33F25E0009, 33F25G0174, 33F25G0682, 33F25L0138, 33F26A0234; ASK-42703-PMSG1/10801902193275/33F25F0363; ASK-42703-POSU3/10801902193275, 10801902222579/33F25D0758, 33F25E0563, 33F25L0109, 33F26A1436, 33F26B0782; ASK-42703-PSAU1/10801902193275, 10801902159486/33F25A0258, 33F25C0300, 33F25D0543, 33F25J0108, 33F25J0273, 33F25M0093, 33F26B0758; ASK-42703-RHR1/10801902193275, 10801902163643/33F25E0311, 33F25G0262, 33F25H0425, 33F25L0060, 33F26A0238, 33F26C0483; ASK-42802-DU1/10801902161007, 10801902193275/33F24C0924, 33F24F0870, 33F24L0870, 33F25D0356, 33F25E0566, 33F25F0191, 33F25J0285, 33F26B0423; ASK-42802-PHF4/10801902200485, 10801902193275/33F24F0759, 33F25B0357, 33F25B0478, 33F25E0568, 33F25F0079, 33F25G0176, 33F25J0392, 33F25M0059, 33F26A1528, 33F26B0190, 33F26B0793; ASK-42802-PHHN1/10801902193275/33F25E0004, 33F25G0265, 33F25K0045, 33F25M0065; ASK-42802-POSU3/10801902193275, 10801902222586/33F25D0759, 33F25E0569, 33F25F0193, 33F25G0186, 33F25J0393, 33F26A1548, 33F26B0859; ASK-42802-PUCD1/10801902193275/33F25E0313, 33F25E1206; ASK-42802-PWHC1/10801902193275, 10801902134858/33F25B0498, 33F25E0680, 33F25F0195, 33F25J0160, 33F26B0418, 33F26C0164; ASK-42802-UHC/10801902193275, 10801902159745/33F25C0306, 33F25E0605, 33F25J0289, 33F26B0200; ASK-42854-MCY1/10801902193275, 10801902220995/33F24H0126, 33F24J0099, 33F25B0479, 33F25E0570, 33F25F0196, 33F25J0396, 33F26B0779; ASK-45703-BCH/10801902193275, 10801902222784/33F25F0004, 33F25F0117, 33F25G0184, 33F25G0185, 33F25H0508, 33F26A1381, 33F26B0876; ASK-45703-EMC/10801902160468, 10801902193275/33F24D0579, 33F24L0911, 33F25D0411, 33F25G0406, 33F25M0181, 33F26C0225; ASK-45703-MHMC1/10801902193275, 10801902213850/33F25B0580, 33F25D0366, 33F25E0574, 33F25G0224, 33F25H0463, 33F25J0231, 33F26B0129; ASK-45703-NWM/10801902193275/33F25F0006, 33F25F0105, 33F25M0009, 33F26A1463; ASK-45703-PCOR/10801902193275/33F24L0088, 33F25C0736, 33F25H0755; ASK-45703-PIMH/10801902193275/33F25B0588; ASK-45703-PK/10801902193275/33F25A0271, 33F25E0623; ASK-45703-PLGH2/10801902144536, 10801902193275/33F24D0901, 33F24F0995, 33F24L0213, 33F24L0964, 33F25C0315; ASK-45703-PMM4/10801902193275/33F25A0272; ASK-45703-PMM5/10801902193275, 10801902221947/33F25E0505, 33F25E0624, 33F25G0192, 33F25L0105, 33F25L0269, 33F26A1368, 33F26B0207, 33F26C0153; ASK-45703-POSU3/10801902193275, 10801902222593/33F25D0760, 33F25E0576, 33F25E0686, 33F25M0097, 33F26A1346, 33F26B0148, ASK-45703-PPHP1/10801902193275/33F24K0067, 33F25C0584, 33F25G0555, 33F26A0240; ASK-45703-PSAM/10801902116373, 10801902193275/33F24E0560, 33F24G0518, 33F24J0638, 33F25C0818, 33F25G0144, 33F25J0931, 33F26B0509; ASK-45703-PUCD1/10801902193275, 10801902221640/33F25D0237, 33F25D0607, 33F25H0653, 33F25K0159, 33F25M0228, 33F26A1499, 33F26B0374; ASK-45703-PUNCC2/10801902164268, 10801902193275/33F24D0696, 33F24F0690, 33F24K0439, 33F25B0598,33F25D0373, 33F25E0690, 33F25F0147, 33F25H0204, 33F25H0631, 33F25J0233, 33F26B0415; ASK-45854-PAMC1/10801902193275/33F25C0363, 33F25H0519, 33F25K0162, 33F26A0524; ASK-45854-PLGH1/10801902193275/33F24L0191, 33F25B0361, 33F25E0309, 33F25H0775, 33F26A0247; CDC-45802-XPN1A/10801902193275/33F25A0290, 33F25B0632, 33F25E0757, 33F25J0255, 33F26A1565; CDC-42703-XPN1A/10801902193275, 10801902162066/33F25F0069, 33F25F0332, 33F25H0879, 33F25H0881, 33F25J0224, 33F25J0693, 33F25J0697, 33F25J0717, 33F25J0721, 33F25L0014, 33F25L0250, 33F25M0019, 33F25M0028,33F26A0312, 33F26A0338, 33F26B0624, 33F26C0066, 33F26C0074, 33F26C0087, 33F26C0101, 36F25A0010, 36F25B0035, 36F25B0038, 36F25B0069, 36F25E0017, 36F25G0013, 36F25H0001, 36F25H0002, 36F25H0026, 36F25J0003; CDC-45703-PB1A/10801902117202, 10801902193275/33F24C1072, 33F24E0626, 33F24F0945, 33F25E0754, 33F25G0581, 33F25H0435, 33F25J0118, 33F25J0328; CDC-45854-P1A/30801902117275/33F24D0700, 33F24F0086, 33F24F0794, 33F25C0210, 33F25D0571, 33F25E0705, 33F25G0276, 33F25H0444, 33F25J0121, 33F25J0184, 33F25K0191, 33F26A1558, 33F26B0886;
Other Recalls from ARROW INTERNATIONAL, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2388-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 F... | Apr 21, 2026 |
| Z-2371-2026 | Class I | Description/REF: EPIDURAL CATHETER KIT: 19 GA ... | Apr 21, 2026 |
| Z-2367-2026 | Class I | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x... | Apr 21, 2026 |
| Z-2386-2026 | Class I | Description/REF: PARACENTESIS KIT/ASK-00376-JHH | Apr 21, 2026 |
| Z-2379-2026 | Class I | Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM... | Apr 21, 2026 |
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.