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-1361-2018 | Class II | Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems... | Crimson Trace Corporation | REU | |
| Z-0967-2018 | Class II | SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS... | Ortho Solutions Inc | HWC | |
| Z-0185-2018 | Class II | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a... | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-0113-2018 | Class II | MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12... | MEDLINE INDUSTRIES, LP - Northfield | BSY | |
| Z-0112-2018 | Class II | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | MEDLINE INDUSTRIES, LP - Northfield | BSY | |
| Z-0670-2018 | Class II | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy... | Medtronic, Inc. | OZO | |
| Z-0098-2018 | Class II | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box... | Karl Storz Endoscopy-America, Inc. | NKC | |
| Z-0538-2018 | Class II | Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size... | Exactech, Inc. | MEH | |
| Z-0592-2018 | Class II | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075... | Cepheid | LSL | |
| Z-0407-2018 | Class II | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S | Inovo Inc. | CAW | |
| Z-0972-2018 | Class II | Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use... | West Pharma. Services IL, Ltd. | LHI | |
| Z-1131-2018 | Class II | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB... | CooperSurgical, Inc. | KNG | |
| Z-0642-2018 | Class II | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients... | Allen Medical Systems, Inc. | JEB | |
| Z-0641-2018 | Class II | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for... | Allen Medical Systems, Inc. | JEB | |
| Z-0971-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN... | Baxter Healthcare Corporation | FRN | |
| Z-0521-2018 | Class II | Philips Ingenuity CT computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0520-2018 | Class II | Philips Ingenuity Core 128 computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0519-2018 | Class II | Philips Ingenuity Core computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0518-2018 | Class II | Philips Brilliance 64 computed tomography x-ray system | Philips North America LLC | JAK | |
| Z-0125-2018 | Class II | NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD*... | Halyard Health | BSY | |
| Z-0124-2018 | Class II | Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit... | Halyard Health | BSY | |
| Z-0123-2018 | Class II | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12... | Halyard Health | BSY | |
| Z-0122-2018 | Class II | Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit... | Halyard Health | BSY | |
| Z-0121-2018 | Class II | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials... | Halyard Health | BSY | |
| Z-0120-2018 | Class II | Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials... | Halyard Health | BSY | |
| Z-0119-2018 | Class II | Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20... | Halyard Health | BSY | |
| Z-0118-2018 | Class II | Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline... | Halyard Health | BSY | |
| Z-0117-2018 | Class II | Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials... | Halyard Health | BSY | |
| Z-0829-2018 | Class II | 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-0850-2018 | Class II | Philips Network Firewall (Cisco ASA 5506), Model # 867098 | Philips North America LLC | MHX | |
| Z-0194-2018 | Class I | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. | Monteris Medical Corp | GEX | |
| Z-0083-2018 | Class II | WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML... | Teleflex Medical | FZP | |
| Z-1199-2018 | Class II | DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver... | GE Healthcare | BSZ | |
| Z-1198-2018 | Class II | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of... | GE Healthcare | CAD | |
| Z-0942-2018 | Class II | INFINITY DUAL HEMO MCable Pod | Draeger Medical Systems, Inc. | MHX | |
| Z-0081-2018 | Class II | RESONATE X4 CRT-D, Model G447, Sterile. | Boston Scientific Corporation | NIK | |
| Z-0080-2018 | Class II | MOMENTUM X4 CRT-D, Model G138, Sterile. | Boston Scientific Corporation | NIK | |
| Z-0079-2018 | Class II | VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy... | Boston Scientific Corporation | NIK | |
| Z-0078-2018 | Class II | RESONATE EL ICD DR, Model D433, Sterile. | Boston Scientific Corporation | LWS | |
| Z-0077-2018 | Class II | RESONATE EL ICD VR, Model D432, Sterile. | Boston Scientific Corporation | LWS | |
| Z-0933-2018 | Class II | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when... | Vygon Mfg | LRS | |
| Z-1011-2018 | Class II | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty | Zimmer GmbH | MBH | |
| Z-0935-2018 | Class II | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially... | Becton Dickinson & Co | JSO | |
| Z-0919-2018 | Class II | Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip... | Zimmer GmbH | LXH | |
| Z-0918-2018 | Class II | Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in... | Zimmer GmbH | LXH | |
| Z-0899-2018 | Class III | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number... | Degania Silicone, Inc. | GBX | |
| Z-0095-2018 | Class II | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC... | Arthrex GmbH | HSX | |
| Z-0714-2018 | Class II | SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0713-2018 | Class II | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0496-2018 | Class II | Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10... | Edwards Lifesciences LLC | DQK |