28 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
FDA Recall
Open, Classified
·Sklar Instruments·Product code KAD·December 3, 2024
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
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAD·November 24, 2025
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAD·November 24, 2025
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code CAD·November 18, 2024
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12
FDA Recall
Open, Classified
·Product code GAP·December 21, 2023
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Recall
Open, Classified
·Bio-Rad Laboratories·Product code OYX·February 15, 2024
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code MID·February 28, 2023
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc·Product code JJE·January 10, 2019
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·April 14, 2022
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·April 21, 2020
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023