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-2691-2017 | Class II | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product... | Abbott Medical | LGW | |
| Z-0213-2018 | Class I | St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm... | Sterilmed Inc | DYB | |
| Z-0590-2018 | Class III | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | C.R. Bard Inc | DWJ | |
| Z-0233-2018 | Class II | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May... | Dukal LLC | FPY | |
| Z-0198-2018 | Class III | BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use... | Becton Dickinson & Co | JQX | |
| Z-3048-2017 | Class II | VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz... | Solta Medical, Inc. | ||
| Z-3047-2017 | Class II | VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser... | Solta Medical, Inc. | ||
| Z-3079-2017 | Class II | MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve... | Principle & Will Biotech (Pinghu) Co., Ltd. | FYA | |
| Z-0182-2018 | Class II | ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0181-2018 | Class II | ARROW PICC powered by ARROW VPS Stylet The Pressure Injectable PICC is indicated for... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0180-2018 | Class II | ARROW PICC powered by ARROW VPS Stylet The Pressure Injectable PICC is indicated for... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0179-2018 | Class II | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | OBJ | |
| Z-3066-2017 | Class II | Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and... | Summit Medical, LLC | N/A | |
| Z-3065-2017 | Class II | Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and... | Summit Medical, LLC | N/A | |
| Z-3064-2017 | Class II | Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer... | Summit Medical, LLC | N/A | |
| Z-3063-2017 | Class II | Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer... | Summit Medical, LLC | N/A | |
| Z-3062-2017 | Class II | Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and... | Summit Medical, LLC | KYZ | |
| Z-3061-2017 | Class II | Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and... | Summit Medical, LLC | N/A | |
| Z-3060-2017 | Class II | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer... | Summit Medical, LLC | KYZ | |
| Z-2674-2017 | Class II | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN... | Boston Scientific Corporation | FGE | |
| Z-2673-2017 | Class II | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN... | Boston Scientific Corporation | FGE | |
| Z-2630-2017 | Class II | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is... | Intuitive Surgical, Inc. | NAY | |
| Z-2865-2017 | Class II | SoftLab Software Laboratory information system to be used in a medical research or... | SCC Soft Computer | NSX | |
| Z-2756-2017 | Class III | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is... | Revvity Health Sciences, Inc. | PJC | |
| Z-0207-2018 | Class II | BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are... | Becton Dickinson & Co | FMI | |
| Z-2659-2017 | Class II | 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The... | Encore Medical, LP | JWH | |
| Z-2658-2017 | Class II | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The... | Encore Medical, LP | JWH | |
| Z-2322-2017 | Class II | Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number... | Philips North America LLC | KPR | |
| Z-2724-2017 | Class II | 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow... | Abbott Medical | FMG | |
| Z-2723-2017 | Class II | 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer... | Abbott Medical | FMG | |
| Z-2722-2017 | Class II | 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow... | Abbott Medical | FMG | |
| Z-2721-2017 | Class II | Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use... | Abbott Medical | FMG | |
| Z-2720-2017 | Class II | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve... | Abbott Medical | FMG | |
| Z-2719-2017 | Class II | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave... | Abbott Medical | FMG | |
| Z-2718-2017 | Class II | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave... | Abbott Medical | FMG | |
| Z-2717-2017 | Class II | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check... | Abbott Medical | FMG | |
| Z-2716-2017 | Class II | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave... | Abbott Medical | FMG | |
| Z-2626-2017 | Class II | ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH... | EOS imaging | IKX | |
| Z-2625-2017 | Class II | LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c)... | Smith & Nephew, Inc. | JWH | |
| Z-2624-2017 | Class II | LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c)... | Smith & Nephew, Inc. | JWH | |
| Z-0533-2018 | Class II | 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter... | Medical Components, Inc. | LJT | |
| Z-3081-2017 | Class II | LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic... | Alcon Laboratories | HRM | |
| Z-0183-2018 | Class II | BD Insulin Syringes with the BD Ultra-Fine(TM) needle mL 12.7mm 30G, Catalog/REF... | Becton Dickinson & Co | FMF | |
| Z-2761-2017 | Class II | Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number... | Atrium Medical Corporation | JCT | |
| Z-2651-2017 | Class II | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries)... | Eastman Kodak Company | IZL | |
| Z-2668-2017 | Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38... | Exactech, Inc. | HTX | |
| Z-2667-2017 | Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01 | Exactech, Inc. | HTX | |
| Z-2666-2017 | Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #... | Exactech, Inc. | HTX | |
| Z-2665-2017 | Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01 | Exactech, Inc. | HTX | |
| Z-2664-2017 | Class II | EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and... | Exactech, Inc. | HTX |