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-1424-2019 | Class II | Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145 | Zimmer GmbH | HTW | |
| Z-1423-2019 | Class II | Drill, 2.5x135mm, AO, Item Number 502015142 | Zimmer GmbH | HTW | |
| Z-1422-2019 | Class II | Drill, 2.5x87mm, AO, Item Number 502015137 | Zimmer GmbH | HTW | |
| Z-1421-2019 | Class II | Drill, 2.5x94mm, Stryker, Item Number 502015136 | Zimmer GmbH | HTW | |
| Z-1420-2019 | Class II | Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131 | Zimmer GmbH | HTW | |
| Z-1419-2019 | Class II | Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130 | Zimmer GmbH | HTW | |
| Z-1418-2019 | Class II | Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124 | Zimmer GmbH | HTW | |
| Z-1417-2019 | Class II | Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120 | Zimmer GmbH | HTW | |
| Z-1416-2019 | Class II | Drill, 15mm stop, 1x76mm, AO , Item Number 502015115 | Zimmer GmbH | HTW | |
| Z-1415-2019 | Class II | Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114 | Zimmer GmbH | HTW | |
| Z-1414-2019 | Class II | Drill Sys2.7, 2x103mm, AO, Item Number 502015107 | Zimmer GmbH | HTW | |
| Z-1312-2019 | Class I | LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20... | Integra LifeSciences Corporation | JXG | |
| Z-1311-2019 | Class I | MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage... | Integra LifeSciences Corporation | JXG | |
| Z-1310-2019 | Class I | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way... | Integra LifeSciences Corporation | JXG | |
| Z-1413-2019 | Class II | Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 | Zimmer GmbH | HTW | |
| Z-1348-2019 | Class II | MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S | Compass Health Brands (Corporate Office) | JOW | |
| Z-1347-2019 | Class II | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S | Compass Health Brands (Corporate Office) | JOW | |
| Z-1346-2019 | Class II | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S | Compass Health Brands (Corporate Office) | JOW | |
| Z-1345-2019 | Class II | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model... | Compass Health Brands (Corporate Office) | JOW | |
| Z-1344-2019 | Class II | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model... | Compass Health Brands (Corporate Office) | JOW | |
| Z-1343-2019 | Class II | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S | Compass Health Brands (Corporate Office) | JOW | |
| Z-1226-2019 | Class II | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23... | DePuy Spine, Inc. | MAX | |
| Z-1225-2019 | Class II | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21... | DePuy Spine, Inc. | MAX | |
| Z-1493-2019 | Class II | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers... | Abbott Medical | OAE | |
| Z-1497-2019 | Class II | Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo... | Abbott Medical | JJE | |
| Z-1441-2020 | Class III | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI... | Advanced Bionics LLC | MCM | |
| Z-1928-2019 | Class III | cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample... | Roche Diagnostics GmbH | JQP | |
| Z-1927-2019 | Class III | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample... | Roche Diagnostics GmbH | JQP | |
| Z-1800-2020 | Class II | Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot... | Bio-Rad Labs | MVM | |
| Z-1902-2020 | Class II | DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF... | Delfi Medical Innovations, Inc. | KCY | |
| Z-1901-2020 | Class II | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single... | Delfi Medical Innovations, Inc. | KCY | |
| Z-1699-2019 | Class III | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | |
| Z-1390-2019 | Class II | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number... | Thommen Medical AG | NDP | |
| Z-1314-2019 | Class II | BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit... | Becton Dickinson & Co | PSZ | |
| Z-1313-2019 | Class II | BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System... | Becton Dickinson & Co | PSZ | |
| Z-1255-2019 | Class II | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This... | Randox Laboratories, Limited | JBL | |
| Z-1254-2019 | Class II | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product... | Randox Laboratories, Limited | JBL | |
| Z-1297-2019 | Class II | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is... | Elekta Limited | IYE | |
| Z-2478-2020 | Class II | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437... | Ortho Organizers Inc | EJF | |
| Z-2477-2020 | Class II | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233... | Ortho Organizers Inc | EJF | |
| Z-1873-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05 | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1872-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28 | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1871-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1870-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1869-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20 | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1868-2019 | Class II | Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10 | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1867-2019 | Class II | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1866-2019 | Class II | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-1865-2019 | Class II | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number... | Thermo Fisher Scientific (Asheville) LLC | JTQ | |
| Z-2260-2020 | Class II | da Vinci SP surgical system | Intuitive Surgical, Inc. | NAY |