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-1349-2022 | Class II | CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 | Zeltiq Aesthetics Inc | OOK | |
| Z-1348-2022 | Class II | CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 | Zeltiq Aesthetics Inc | OOK | |
| Z-1347-2022 | Class II | CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 | Zeltiq Aesthetics Inc | OOK | |
| Z-1346-2022 | Class II | CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 | Zeltiq Aesthetics Inc | OOK | |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and... | GE Healthcare | LLZ | |
| Z-1320-2022 | Class I | Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and... | Medtronic, Inc. | MSD | |
| Z-1319-2022 | Class I | Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic... | Medtronic, Inc. | MSD | |
| Z-1318-2022 | Class I | Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic... | Medtronic, Inc. | MSD | |
| Z-1317-2022 | Class I | Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic... | Medtronic, Inc. | MSD | |
| Z-1316-2022 | Class I | Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute... | Medtronic, Inc. | MSD | |
| Z-1315-2022 | Class I | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and... | Medtronic, Inc. | MSD | |
| Z-1314-2022 | Class I | Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular... | Medtronic, Inc. | MSD | |
| Z-1313-2022 | Class I | Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular... | Medtronic, Inc. | MSD | |
| Z-1312-2022 | Class I | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access... | Medtronic, Inc. | MSD | |
| Z-1467-2022 | Class II | TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the... | Medtronic, Inc. | HIH | |
| Z-1305-2022 | Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1304-2022 | Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1477-2022 | Class II | Kits contain leaking bottles of isopropyl alcohol | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-1476-2022 | Class II | Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM... | MEDLINE INDUSTRIES, LP - Northfield | OJG | |
| Z-1475-2022 | Class II | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY... | MEDLINE INDUSTRIES, LP - Northfield | OJU | |
| Z-1474-2022 | Class II | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1473-2022 | Class II | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-1472-2022 | Class II | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-1471-2022 | Class II | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-1470-2022 | Class II | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-1572-2022 | Class II | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers... | Safe Orthopaedics | NKB | |
| Z-1408-2022 | Class II | Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. | ROi CPS LLC | OHM | |
| Z-1407-2022 | Class II | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle... | ROi CPS LLC | OEZ | |
| Z-1420-2022 | Class II | Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and... | Ambu Inc. | CBI | |
| Z-1386-2022 | Class II | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF... | Stryker Corp. | DQO | |
| Z-1388-2022 | Class II | Hobbs Medical Polypectomy Snare, Catalog No. 7202 | Hobbs Medical, Inc. | OCZ | |
| Z-1396-2022 | Class II | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | Surgical Innovations Ltd | GCJ | |
| Z-1382-2022 | Class II | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support... | Breas Medical AB | NOU | |
| Z-1300-2022 | Class II | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the... | Changzhou Biomet Medical Devices Co., Ltd. | LXT | |
| Z-1309-2022 | Class II | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A | Skytron, LLC | FQO | |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700... | GE Healthcare | IZZ | |
| Z-1291-2022 | Class II | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an... | Wright Medical Technology Inc | HSN | |
| Z-1403-2022 | Class II | RayStation 9B SP1. For radiation treatment planning. | RaySearch Laboratories AB (publ) | MUJ | |
| Z-1368-2022 | Class II | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro... | Ultradent Products Inc. | KLE | |
| Z-1374-2022 | Class II | Ventana HE 600 System, automated slide preparer, for use in laboratories. | Ventana Medical Systems Inc | KPA | |
| Z-1372-2022 | Class II | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative... | Siemens Healthcare Diagnostics Inc. | CHL | |
| Z-1389-2022 | Class I | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and... | GE Healthcare | BSZ | |
| Z-1311-2022 | Class II | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-1351-2022 | Class II | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon... | Spectranetics Corp. | LPC | |
| Z-1513-2022 | Class II | Xhibit Telemetry Receiver, Model: 96280 | GE Healthcare | MHX | |
| Z-1392-2022 | Class III | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Boston Scientific Corporation | GEX | |
| Z-1371-2022 | Class II | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-1370-2022 | Class II | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-1393-2022 | Class III | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part #... | Synapse Biomedical Inc | OIR | |
| Z-1306-2022 | Class II | NaviCare Nurse Call/Voalte Nurse Call | Baxter Healthcare Corporation | ILQ |