510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 172 of 1190
FDA device recalls, page 172 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1105-2024Class IMEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF...MEDLINE INDUSTRIES, LP - NorthfieldPEV
Z-1104-2024Class IMEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-1103-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-1102-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1155-2024Class IIThe INFX-8000F is designed to take advantage of the latest technological innovations to...Canon Medical Systems USA, Inc.OWB
Z-1154-2024Class IIThe device is an X-ray system that is capable of radiographic and fluoroscopic studies...Canon Medical Systems USA, Inc.OWB
Z-1101-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1100-2024Class IMEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545MEDLINE INDUSTRIES, LP - NorthfieldJKA
Z-1099-2024Class ICenturion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1098-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1097-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1096-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1095-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b)...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1094-2024Class IMedline Arterial Bundle No Catheter, Ref Art995MEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-1093-2024Class IMedline Bronchoscopy Tray, Ref Dyndl1350aMEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-1092-2024Class IMEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA...MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-1091-2024Class IMEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-1090-2024Class IMedline Tray Trach Basic Solution, Ref Dynd40511MEDLINE INDUSTRIES, LP - NorthfieldCAE
Z-1005-2024Class IIGuardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3...Medtronic, Inc.OZP
Z-0695-2024Class IISoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.SoClean, Inc.QXQ
Z-0694-2024Class IISoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance SystemSoClean, Inc.QXQ
Z-0616-2024Class IILandauer microSTARii reader, Medical Dosimetry System, Model Numbers...LandauerIYE
Z-0550-2024Class IIBaxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479Baxter Healthcare CorporationFKX
Z-0554-2024Class IISensica Urine Output System, Catalog Number SCCS1002C.R. Bard IncEXS
Z-0509-2024Class IISpectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics...Spectranetics Corp.MCW
Z-0676-2024Class IIBD Recanalization System, REF: BDRECANSYSTEMBard Peripheral Vascular IncPDU
Z-0595-2024Class IIICARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal...Maquet Cardiovascular Us Sales, LLCDTQ
Z-0708-2024Class IICORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013SBlue Belt Technologies, Inc.OLO
Z-0751-2024Class IICalibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530)...Randox Laboratories, LimitedJIX
Z-0617-2024Class IIHookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru...STERIS CorporationFEB
Z-0605-2024Class IIVenous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i...Maquet Cardiovascular Us Sales, LLCDTQ
Z-0615-2024Class IIMedtronic SynchroMed II, Model 8637-40, Programmable pumpMedtronic NeuromodulationLKK
Z-0614-2024Class IIMedtronic SynchroMed II, Model 8637-20, Programmable pumpMedtronic NeuromodulationLKK
Z-0944-2024Class IIEZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures...OLYMPUS Corporation of the AmericasFGE
Z-0943-2024Class IIEZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in...OLYMPUS Corporation of the AmericasFGE
Z-0942-2024Class IIEZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of...OLYMPUS Corporation of the AmericasFGE
Z-0941-2024Class IIEZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in...OLYMPUS Corporation of the AmericasFGE
Z-0940-2024Class IIEZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of...OLYMPUS Corporation of the AmericasFGE
Z-0939-2024Class IIEZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in...OLYMPUS Corporation of the AmericasFGE
Z-0938-2024Class IIEZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of...OLYMPUS Corporation of the AmericasFGE
Z-0937-2024Class IIEZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of...OLYMPUS Corporation of the AmericasFGE
Z-0936-2024Class IIEZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of...OLYMPUS Corporation of the AmericasFGE
Z-0935-2024Class IIEZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of...OLYMPUS Corporation of the AmericasFGE
Z-0934-2024Class IIEZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures...OLYMPUS Corporation of the AmericasFGE
Z-0933-2024Class IIEZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the...OLYMPUS Corporation of the AmericasFGE
Z-0747-2024Class II48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694RAbbott MedicalDRS
Z-0746-2024Class IIMedex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682RAbbott MedicalDRS
Z-0745-2024Class II20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BRAbbott MedicalDRS
Z-0744-2024Class IIHIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HPAbbott MedicalDRS
Z-0743-2024Class IIHIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HPAbbott MedicalDRS