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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1323-2020 | Class II | Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended... | Nobel Biocare USA LLC | DZI | |
| Z-1322-2020 | Class II | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment... | Nobel Biocare USA LLC | NDP | |
| Z-1321-2020 | Class II | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to... | Nobel Biocare USA LLC | NDP | |
| Z-1320-2020 | Class II | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be... | Nobel Biocare USA LLC | NDP | |
| Z-1319-2020 | Class II | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used... | Nobel Biocare USA LLC | NDP | |
| Z-1318-2020 | Class II | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove... | Nobel Biocare USA LLC | NDP | |
| Z-1317-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used... | Nobel Biocare USA LLC | NDP | |
| Z-1316-2020 | Class II | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to... | Nobel Biocare USA LLC | NDP | |
| Z-1315-2020 | Class II | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in... | Nobel Biocare USA LLC | DZI | |
| Z-1314-2020 | Class II | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used... | Nobel Biocare USA LLC | DZI | |
| Z-1313-2020 | Class II | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in... | Nobel Biocare USA LLC | DZI | |
| Z-1312-2020 | Class II | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in... | Nobel Biocare USA LLC | DZI | |
| Z-1311-2020 | Class II | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in... | Nobel Biocare USA LLC | DZI | |
| Z-1310-2020 | Class II | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1309-2020 | Class II | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1308-2020 | Class II | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1307-2020 | Class II | Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1306-2020 | Class II | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1305-2020 | Class II | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills... | Nobel Biocare USA LLC | DZI | |
| Z-1304-2020 | Class II | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZI | |
| Z-1303-2020 | Class II | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step)... | Nobel Biocare USA LLC | DZi | |
| Z-1302-2020 | Class II | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist... | Nobel Biocare USA LLC | DZE | |
| Z-0799-2020 | Class II | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates... | Trilliant Surgical LLC | HXX | |
| Z-2217-2019 | Class II | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No... | Medical Components, Inc. | LFJ | |
| Z-2216-2019 | Class II | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No... | Medical Components, Inc. | LFJ | |
| Z-2215-2019 | Class II | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No... | Medical Components, Inc. | LFJ | |
| Z-1213-2019 | Class II | Procedure kits include devices from the affected lots distributed OUS only: (1)BOX... | Medtronic, Inc. | HDA | |
| Z-1208-2019 | Class II | Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product... | Exactech, Inc. | JWH | |
| Z-1212-2019 | Class II | Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto... | Medtronic, Inc. | HDA | |
| Z-1211-2019 | Class II | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch"... | Medtronic, Inc. | HDA | |
| Z-1149-2019 | Class II | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 | Medical Components, Inc. | LFJ | |
| Z-1386-2019 | Class I | enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy... | Jaeger Medical GmbH | LGZ | |
| Z-1385-2019 | Class I | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood... | Jaeger Medical GmbH | LGZ | |
| Z-1130-2019 | Class II | Azurion FlexArm, 722079 | Philips North America LLC | JAA | |
| Z-1136-2019 | Class II | PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in... | Ethicon, Inc | NEW | |
| Z-1135-2019 | Class II | VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0... | Ethicon, Inc | NEW | |
| Z-1134-2019 | Class II | VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL... | Ethicon, Inc | GAM | |
| Z-1109-2019 | Class II | Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using... | Elekta Limited | IYE | |
| Z-1111-2019 | Class II | Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract... | Becton Dickinson & Co | HNN | |
| Z-1205-2019 | Class II | RT Elements Software revisions of the RT Elements applications have a specific software... | Brainlab, Inc. | MUJ | |
| Z-1131-2019 | Class II | ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power... | Johnson & Johnson Vision Care, Inc. | LPL | |
| Z-1785-2019 | Class II | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 | Randox Laboratories, Limited | JJY | |
| Z-1222-2019 | Class II | VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1126-2019 | Class II | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final... | ulrich medical USA Inc | LXL | |
| Z-1187-2019 | Class II | Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS | Gyrus ACMI, Inc. | GEI | |
| Z-1186-2019 | Class II | Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS | Gyrus ACMI, Inc. | GEI | |
| Z-1185-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC | Gyrus ACMI, Inc. | GEI | |
| Z-1184-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS | Gyrus ACMI, Inc. | GEI | |
| Z-1183-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC | Gyrus ACMI, Inc. | GEI | |
| Z-1182-2019 | Class II | Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS | Gyrus ACMI, Inc. | GEI |