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-0547-2021 | Class II | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of... | Randox Laboratories, Limited | JGJ | |
| Z-0783-2021 | Class II | Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-0782-2021 | Class II | Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0546-2021 | Class II | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in... | Randox Laboratories, Limited | JGJ | |
| Z-0781-2021 | Class II | Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-0780-2021 | Class II | Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-0779-2021 | Class II | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-0843-2021 | Class II | CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System... | Medtronic, Inc. | MDS | |
| Z-0860-2021 | Class II | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer... | Medtronic Neuromodulation | LGW | |
| Z-0535-2021 | Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic... | LivaNova USA, Inc. | LYJ | |
| Z-0484-2021 | Class II | Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model... | Hill-Rom Manufacturing, Inc. | CBK | |
| Z-0638-2021 | Class II | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler... | Biocomposites, Ltd. | MQV | |
| Z-0651-2021 | Class II | Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for... | ConMed Corporation | LXH | |
| Z-0650-2021 | Class II | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for... | ConMed Corporation | LXH | |
| Z-0142-2022 | Class II | Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A | Canon Medical Systems USA, Inc. | KPS | |
| Z-0746-2021 | Class II | REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female... | Westmed Inc | KGB | |
| Z-0745-2021 | Class II | REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an... | Westmed Inc | KGB | |
| Z-0744-2021 | Class II | REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer... | Westmed Inc | KGB | |
| Z-0743-2021 | Class II | REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X... | Westmed Inc | KGB | |
| Z-0742-2021 | Class II | Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only... | Westmed Inc | KGB | |
| Z-0741-2021 | Class II | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only... | Westmed Inc | KGB | |
| Z-0548-2021 | Class II | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid... | Integra LifeSciences Corporation | HBL | |
| Z-0589-2021 | Class II | RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0753-2021 | Class II | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom... | Intersurgical Ltd. | OFP | |
| Z-0565-2021 | Class II | (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC... | Terumo Cardiovascular Systems Corporation | DTZ | |
| Z-0553-2021 | Class II | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance... | Mortara Instrument, Inc. | DPS | |
| Z-0653-2021 | Class II | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue... | Artivion, Inc. | DXZ | |
| Z-0652-2021 | Class II | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture... | Artivion, Inc. | OHA | |
| Z-0768-2021 | Class II | MiniCap Extended Life PD Transfer Set | Baxter Healthcare Corporation | KDJ | |
| Z-0751-2021 | Class II | Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx... | Merit Medical Systems, Inc. | OEQ | |
| Z-0750-2021 | Class II | Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO... | Merit Medical Systems, Inc. | OEQ | |
| Z-0749-2021 | Class II | Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only... | Merit Medical Systems, Inc. | OEQ | |
| Z-0698-2021 | Class III | AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN... | Applied Medical Technology Inc | PIO | |
| Z-0552-2021 | Class II | PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. | BioTissue Holdings Inc. | NQB | |
| Z-0551-2021 | Class II | PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage. | BioTissue Holdings Inc. | NQB | |
| Z-0550-2021 | Class II | PROKERA, non-sterile - Product Usage: Biologic corneal bandage. | BioTissue Holdings Inc. | NQB | |
| Z-0737-2021 | Class II | Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard... | ROi CPS LLC | EFQ | |
| Z-0549-2021 | Class II | Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage... | Canon Medical Systems USA, Inc. | JAK | |
| Z-0859-2021 | Class II | icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients... | Abbott Medical | DXG | |
| Z-0635-2021 | Class II | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING... | Helena Laboratories, Corp. | JPA | |
| Z-0884-2021 | Class II | Equinoxe Humeral Stem, Primary, Press Fit, 11mm | Exactech, Inc. | HSD | |
| Z-0534-2021 | Class II | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle... | Shimadzu Medical Systems | IZL | |
| Z-0829-2021 | Class II | Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0828-2021 | Class II | Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0827-2021 | Class II | Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0826-2021 | Class II | NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0825-2021 | Class II | NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0824-2021 | Class II | NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0823-2021 | Class II | NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0822-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO |