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-0708-2020 | Class II | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The... | Rhondium Limited | EBF | |
| Z-0982-2019 | Class II | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Microbiologics, Inc. | PMN | |
| Z-0174-2020 | Class II | Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the... | MEDLINE INDUSTRIES, LP - Northfield | KDQ | |
| Z-1823-2020 | Class II | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407... | CG MedTech Co., Ltd. | OVE | |
| Z-1224-2019 | Class II | OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical... | MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA | KKY | |
| Z-1223-2019 | Class II | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical... | MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA | KKY | |
| Z-1784-2019 | Class II | TASE 500 Imaging systems | Collins Aerospace | RET | |
| Z-1783-2019 | Class II | TASE 400 Imaging systems | Collins Aerospace | RET | |
| Z-1119-2020 | Class III | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly... | LivaNova USA, Inc. | DTQ | |
| Z-2353-2019 | Class II | ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2352-2019 | Class II | ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2351-2019 | Class II | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2350-2019 | Class II | ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-2035-2019 | Class II | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys... | GE Healthcare | DQK | |
| Z-1959-2019 | Class II | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981... | Applied Medical Resources Corp | GCJ | |
| Z-0732-2020 | Class III | INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 | AAP Implantate AG | HTW | |
| Z-0731-2020 | Class III | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | AAP Implantate AG | HTW | |
| Z-1250-2019 | Class II | Fetal Spiral Electrode, Model No. 9898 031 37631 | Philips North America LLC | HGP | |
| Z-1192-2019 | Class II | Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of... | Medrobotics Corporation | FDF | |
| Z-1191-2019 | Class II | Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of... | Medrobotics Corporation | FDF | |
| Z-1067-2019 | Class II | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF... | Philips North America LLC | MHX | |
| Z-1034-2019 | Class III | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85... | Agfa N.V. | IWZ | |
| Z-0983-2019 | Class II | AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended... | Maquet Cardiovascular LLC | FQH | |
| Z-0992-2019 | Class II | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use... | Ortho-Clinical Diagnostics, Inc. | JGS | |
| Z-0832-2019 | Class II | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | AtriCure, Inc. | OCL | |
| Z-0831-2019 | Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | AtriCure, Inc. | OCL | |
| Z-0830-2019 | Class II | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | AtriCure, Inc. | OCL | |
| Z-0829-2019 | Class II | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | AtriCure, Inc. | OCL | |
| Z-0835-2019 | Class II | Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI... | Edwards Lifesciences LLC | NPT | |
| Z-0980-2019 | Class II | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee... | Stryker Corp. | LRO | |
| Z-1951-2019 | Class II | Revolution CT scanners Product Usage: The system is intended for head, whole body... | GE Healthcare | JAK | |
| Z-0660-2020 | Class II | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The... | Bellus Medical, LLC | QAI | |
| Z-1985-2019 | Class II | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date... | DJO, LLC | JOW | |
| Z-1073-2019 | Class II | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic... | Artivion, Inc. | LWQ | |
| Z-0845-2019 | Class II | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | Medtronic, Inc. | OSR | |
| Z-0796-2019 | Class II | MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices | Medtronic, Inc. | OSR | |
| Z-0795-2019 | Class II | MEDTRONIC CARELINK 2090 programmer | Medtronic, Inc. | OSR | |
| Z-0812-2019 | Class I | vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b)... | Medtronic, Inc. | NVZ | |
| Z-0811-2019 | Class I | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker... | Medtronic, Inc. | NVZ | |
| Z-0810-2019 | Class I | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate... | Medtronic, Inc. | NVZ | |
| Z-0809-2019 | Class I | Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model... | Medtronic, Inc. | NVZ | |
| Z-0808-2019 | Class I | Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model... | Medtronic, Inc. | NVZ | |
| Z-0807-2019 | Class I | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate... | Medtronic, Inc. | NVZ | |
| Z-0806-2019 | Class I | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model... | Medtronic, Inc. | NVZ | |
| Z-1373-2019 | Class II | CHOL+HDL+GLU test strips, REF 2412 | Polymer Technology Systems | CGA | |
| Z-1372-2019 | Class II | Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled... | Polymer Technology Systems | CHH | |
| Z-1371-2019 | Class II | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 | Polymer Technology Systems | CHH | |
| Z-1253-2019 | Class III | Carolina(r) Liquid Chemistries Corp. Etha Rgt. Kit, IVD, Ref St321 | Carolina Liquid Chemistries | DIC | |
| Z-1252-2019 | Class III | Carolina(r) Liquid Chemistries Corp. Etha Rgt. Kit, IVD, Ref St321 | Carolina Liquid Chemistries | DIC | |
| Z-0841-2019 | Class II | daVinci Harmonic ACE Curved Shears | Intuitive Surgical, Inc. | NAY |