8,806 results · 12ms · Sources: EU EUDAMED, US FDA

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Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFB·April 21, 2026

Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-CMC1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU4; PSI KIT: 9 FR X 4 1/8 IN (10CM)/ASK-09903-PCMH1; PSI KIT: 8.5 FR X 10 CM/CDC-09803-1A; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-PHP2; MULTI LUMEN/PSI KIT/ASK-11142-NSU; MULTI-LUMEN/PSI KIT/AK-21242-X; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-DMC; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC1; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-HF5; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDT; 2L MAC KIT: 9 FR DISTAL X 4IN (10 CM)/ASK-21142-UCL1; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-SL1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMH; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UN1; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB/CDC-21142-XN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XCN1A; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-XN1A; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-CO1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH3; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-OHSU3; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-SG2; MULTILUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-UOI1; 2 LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-WHC2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-BID1; AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-BSWH2; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-DU1; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-PCMH1; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UCH2; AGB MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UHC2; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-BSWH2; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-HHC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-MCY1; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM1; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-VCU; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-MCY1; PSI KIT: 9 FR/ASK-29903-MHI; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-OHU4; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UCH2; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UCL1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UHC4; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM1; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29907-LGH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-X1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XCN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/CDC-29903-XN1A; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-AHH; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XN1A; PSI ACCESS TRAY/ASK-04001-MM2; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-GMC; MULTI LUMEN/PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU3

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFC·April 21, 2026

Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code DPS·December 8, 2023

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

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OWL·April 21, 2026

Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-PUCI1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUHC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUMH; MULTI-LUMEN PI CVC KIT: 3-L 7 FR/ASK-42703-PUPM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-SHUF2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-SL1; CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-42703-UMC; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-WHH; CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-CHM; CVC KIT: 2L 8 FR X 16 CM/ASK-42802-LMDT1; PI CATHETER 2L: 8FR X 16CM AGB+/ASK-42802-MCY1; PI CVC KIT: 2L 8FR X 16CM AGB+/ASK-42802-PBSWH2; MULTILUMEN CVC KIT: 2L 8 FR X 6/ASK-42802-POSU2; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUNCC2; PI CVC KIT: 2-L 8 FR/ASK-42802-PUPM1; PI CVC KIT: 2L 8 FR/ASK-42802-TGH1; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-BJC1; CVC KIT: 4L 8.5 FR X (16CM) AGB+/ASK-42854-PBMH; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-PMM; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-PUCH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-ACH; 3L CVC KIT: 7 FR X 20 CM AGB+/ASK-45703-ARM; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BJC1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-BLH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-DU1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-HHC4; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDT1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-LMDTG1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-MCY1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NO; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-NS1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PADV1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PAGP1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAMC1; MULTI LUMEN CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PAU1; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PBSWH2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCSJ2; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PDM1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/A

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LRS·April 21, 2026

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

FDA Recall
Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LRS·April 21, 2026