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-2344-2017 | Class II | VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton. | bioMerieux, Inc. | N/A | |
| Z-2343-2017 | Class II | VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. . | bioMerieux, Inc. | JXB | |
| Z-2342-2017 | Class II | VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton. | bioMerieux, Inc. | LQL | |
| Z-2197-2017 | Class II | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with... | Acumed LLC | KWI | |
| Z-2118-2017 | Class I | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct... | EBI Patient Care, Inc. | LOE | |
| Z-2092-2017 | Class II | VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10... | Vortran Medical Technology 1, Inc | BTL | |
| Z-2091-2017 | Class II | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology... | Vortran Medical Technology 1, Inc | BTL | |
| Z-2341-2017 | Class II | VITEK 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton. | bioMerieux, Inc. | LQM | |
| Z-2069-2017 | Class II | Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then... | Almore International Inc | EKH | |
| Z-2780-2017 | Class II | Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular... | Ortho Solutions Inc | HSB | |
| Z-2629-2017 | Class II | High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes... | OLYMPUS Corporation of the Americas | GCP | |
| Z-2102-2017 | Class II | Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk... | Medical Action Industries, Inc. 306 | GDY | |
| Z-2101-2017 | Class II | White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs. Intended for... | Medical Action Industries, Inc. 306 | GDY | |
| Z-2094-2017 | Class II | ARIES System and ARIES M1 System | Luminex Corporation | OOI | |
| Z-2591-2018 | Class II | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level... | VitalScientific | JIX | |
| Z-2613-2017 | Class II | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle... | Abbott Medical | CDZ | |
| Z-2450-2019 | Class II | SonarMed AirWave Monitor, Model Number M0001 | Sonarmed, Inc. | OQU | |
| Z-2215-2017 | Class II | AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to... | Zimmer GmbH | HSB | |
| Z-2211-2017 | Class II | Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z | Madison Polymeric Engineering | LKB | |
| Z-0253-2018 | Class II | Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic... | ConMed Corporation | MBI | |
| Z-2093-2017 | Class II | Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital... | GE Healthcare | BSZ | |
| Z-2122-2017 | Class II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number... | Cardiovascular Systems Incorporated | MCX | |
| Z-1777-2018 | Class II | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400... | Parker Laboratories, Inc. | IYO | |
| Z-0265-2018 | Class II | ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for... | bioMerieux, Inc. | JWY | |
| Z-0264-2018 | Class II | ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for... | bioMerieux, Inc. | JWY | |
| Z-2745-2017 | Class II | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically... | PENTAX of America, Inc. | GCW | |
| Z-2744-2017 | Class II | 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record... | PENTAX of America, Inc. | GCW | |
| Z-2743-2017 | Class II | 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically... | PENTAX of America, Inc. | GCW | |
| Z-2742-2017 | Class II | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E... | PENTAX of America, Inc. | GCW | |
| Z-2056-2017 | Class II | Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin | Zimmer GmbH | LOD | |
| Z-2047-2017 | Class II | Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only | Medtronic Sofamor Danek USA Inc | LXH | |
| Z-2074-2017 | Class II | Access BR Monitor, Part No. 387620 | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-2657-2017 | Class II | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology... | CardioTek BV | DQK | |
| Z-2980-2018 | Class II | Laser Cds | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-2979-2018 | Class II | Cardiac Insulation Pad, OPEN HEART CDS | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-2978-2018 | Class II | Laparoscopy CDS | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-2977-2018 | Class II | PICC Tray, STERILE, 12 packs each per case. | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-2976-2018 | Class II | Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. | MEDLINE INDUSTRIES, LP - Northfield | N/A | |
| Z-2059-2017 | Class II | Bone Dowell Harvest Tubes | Zimmer GmbH | LXH | |
| Z-2180-2017 | Class II | Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide... | Vascular Solutions LLC | MAV | |
| Z-1880-2017 | Class II | Omega Incline Platform Lift | Savaria Concord Lifts, Inc. | ILK | |
| Z-2060-2017 | Class II | Savaria SL-1000 Stairlift | Savaria Concord Lifts, Inc. | PCD | |
| Z-1882-2017 | Class II | The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved... | Savaria Concord Lifts, Inc. | ILK | |
| Z-2156-2017 | Class II | AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-2164-2017 | Class II | SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... | Datascope Corp. | DSP | |
| Z-2117-2017 | Class II | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D... | Medtronic, Inc. | NIK | |
| Z-1884-2017 | Class II | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is... | Xtant Medical Holdings, Inc. | MNH | |
| Z-1267-2018 | Class II | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of... | Medica Corp. | JIT | |
| Z-2114-2017 | Class II | INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR... | Corcym Inc. | MRM | |
| Z-2113-2017 | Class II | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750... | Corcym Inc. | MRM |