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 43 of 1190
FDA device recalls, page 43 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1137-2026Class IIRifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device...Community Products, LLCFSA
Z-1173-2026Class IIAlternatiV+ Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1172-2026Class IIAlternatiV+ Max Knotless AnchorAju Medical Co., Ltd.MAI
Z-1171-2026Class IIGenesis Push-In Suture AnchorAju Medical Co., Ltd.MAI
Z-1170-2026Class IIGenesis Knotless AnchorAju Medical Co., Ltd.MAI
Z-1169-2026Class IIGenesis Dual Thread Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1168-2026Class IIGenesis Screw-In AnchorAju Medical Co., Ltd.MAI
Z-1167-2026Class IIFixone Biocomposite AnchorAju Medical Co., Ltd.MAI
Z-1166-2026Class IIFixone Hybrid AnchorAju Medical Co., Ltd.MAI
Z-1256-2026Class IIVortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerVortex Surgical, Inc.HMQ
Z-1255-2026Class IIVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27Vortex Surgical, Inc.MXY
Z-1254-2026Class IIVortex Surgical TID Pharos Illuminated Depressor, VS0801BVortex Surgical, Inc.HJM
Z-1253-2026Class IIRumex Disposable Diamond Dusted ILM Elevator, 12-7523Vortex Surgical, Inc.HNQ
Z-1252-2026Class IIVortex Surgical I2 Injection Kit, VS0500Vortex Surgical, Inc.KDD
Z-1251-2026Class IITecfen Retractable Membrane Polisher, QTPR1267-23Vortex Surgical, Inc.HNQ
Z-1250-2026Class IIVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25Vortex Surgical, Inc.MXY
Z-1249-2026Class IIConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit...Vortex Surgical, Inc.KDD
Z-1248-2026Class II25GA Subretinal Injection Cannula VS0220.25Vortex Surgical, Inc.MXY
Z-1247-2026Class IIVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA...Vortex Surgical, Inc.HNR
Z-1246-2026Class IIOertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated...Vortex Surgical, Inc.HQB
Z-1245-2026Class IIVortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe...Vortex Surgical, Inc.HQB
Z-1244-2026Class IIVolk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk...Vortex Surgical, Inc.HJK
Z-1090-2026Class IIMedline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-1089-2026Class IIMedline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-1088-2026Class IIMedline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1087-2026Class IIMedline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1086-2026Class IIMedline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1085-2026Class IIMedline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1298-2026Class IIProduct Name: Nasal Jejunal Feeding Tube REF: NJFT-10Wilson-Cook Medical Inc.KNT
Z-1369-2026Class IIEstrone RIA, REF: DSL8700IMMUNOTECH s.r.o.CGF
Z-1136-2026Class IITS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes...Sysmex America, Inc.LXG
Z-1117-2026Class IBrand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog...Salter LabsOKI
Z-1116-2026Class IBrand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog...Salter LabsOKI
Z-1115-2026Class IBrand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow...Salter LabsOKI
Z-1114-2026Class IBrand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow...Salter LabsOKI
Z-1096-2026Class IIda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073...Intuitive Surgical, Inc.NAY
Z-1077-2026Class IIAllura Xper FD20/20; Model Number: 722038;Philips Medical Systems Nederland B.V.OWB
Z-1076-2026Class IIAllura Xper FD20/10; Model Number: 722029;Philips Medical Systems Nederland B.V.OWB
Z-1075-2026Class IIAllura Xper FD20; Model Number: 722028;Philips Medical Systems Nederland B.V.OWB
Z-1074-2026Class IIAllura Xper FD10/10; Model Number: 722027;Philips Medical Systems Nederland B.V.OWB
Z-1073-2026Class IIAllura Xper FD10; Model Number: 722026;Philips Medical Systems Nederland B.V.OWB
Z-1072-2026Class IIAllura Xper FD20 OR Table; Model Number: 722023;Philips Medical Systems Nederland B.V.OWB
Z-1071-2026Class IIAllura Xper FD20 Biplane; Model Number: 722013;Philips Medical Systems Nederland B.V.OWB
Z-1070-2026Class IIAllura Xper FD20; Model Number: 722012;Philips Medical Systems Nederland B.V.OWB
Z-1069-2026Class IIAllura Xper FD10/10; Model Number: 722011;Philips Medical Systems Nederland B.V.OWB
Z-1068-2026Class IIAllura Xper FD10; Model Number: 722010;Philips Medical Systems Nederland B.V.OWB
Z-1067-2026Class IIAllura Xper FD20 Biplane; Model Number: 722008;Philips Medical Systems Nederland B.V.OWB
Z-1066-2026Class IIAllura Xper FD20; Model Number: 722006;Philips Medical Systems Nederland B.V.OWB
Z-1065-2026Class IIAllura Xper FD10/10; Model Number: 722005;Philips Medical Systems Nederland B.V.OWB
Z-1064-2026Class IIAllura Xper FD10; Model Number: 722003;Philips Medical Systems Nederland B.V.OWB