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-1387-2018 | Class II | Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No... | Preservation Solutions Inc | KDN | |
| Z-2888-2018 | Class II | CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter)... | CIVCO Medical Instruments Co., Inc. | ITX | |
| Z-1510-2018 | Class II | T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile... | Stryker Corp. | FYA | |
| Z-1509-2018 | Class II | T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1508-2018 | Class II | T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1507-2018 | Class II | T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile... | Stryker Corp. | FYA | |
| Z-1506-2018 | Class II | T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1505-2018 | Class II | T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1504-2018 | Class II | T4 Pullover Toga, X-Large; Catalog Number: 0400-770-000 Sterile personal protection... | Stryker Corp. | FYA | |
| Z-1503-2018 | Class II | T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1502-2018 | Class II | T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection... | Stryker Corp. | FYA | |
| Z-1501-2018 | Class II | T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1500-2018 | Class II | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment | Stryker Corp. | FYA | |
| Z-1523-2018 | Class II | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a... | Sofradim Production | FTL | |
| Z-1302-2018 | Class II | GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product... | GE Healthcare | LLZ | |
| Z-1364-2018 | Class II | ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 | Orthofix SRL | NKG | |
| Z-1363-2018 | Class II | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix SRL | NKG | |
| Z-1266-2018 | Class II | IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600 | IMRIS Imaging, Inc. | FQO | |
| Z-1265-2018 | Class II | IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600 | IMRIS Imaging, Inc. | FQO | |
| Z-1264-2018 | Class II | IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b)... | IMRIS Imaging, Inc. | FQO | |
| Z-1263-2018 | Class II | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600 | IMRIS Imaging, Inc. | FQO | |
| Z-1127-2018 | Class II | REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is... | Medical Components, Inc. | NFK | |
| Z-1126-2018 | Class II | CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair... | Medical Components, Inc. | NFK | |
| Z-1125-2018 | Class II | TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit... | Medical Components, Inc. | NFK | |
| Z-1124-2018 | Class II | 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product... | Medical Components, Inc. | NFK | |
| Z-1123-2018 | Class II | 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The... | Medical Components, Inc. | NFK | |
| Z-1122-2018 | Class II | 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product... | Medical Components, Inc. | NFK | |
| Z-1121-2018 | Class II | 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product... | Medical Components, Inc. | NFK | |
| Z-1120-2018 | Class II | 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product... | Medical Components, Inc. | NFK | |
| Z-1119-2018 | Class II | REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is... | Medical Components, Inc. | NFK | |
| Z-1118-2018 | Class II | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair... | Medical Components, Inc. | NFK | |
| Z-1218-2018 | Class II | IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during... | IMRIS Imaging, Inc. | FQO | |
| Z-1217-2018 | Class II | IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during... | IMRIS Imaging, Inc. | FQO | |
| Z-1178-2018 | Class II | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL Connector, REF/Catalog Number 2602Z... | ConMed Corporation | MKJ | |
| Z-1177-2018 | Class II | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control Quik-Combo" Connector... | ConMed Corporation | MKJ | |
| Z-1176-2018 | Class II | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog... | ConMed Corporation | MKJ | |
| Z-1175-2018 | Class II | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog... | ConMed Corporation | MKJ | |
| Z-1174-2018 | Class II | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog... | ConMed Corporation | MKJ | |
| Z-1613-2018 | Class II | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche... | Roche Diagnostics GmbH | CEM | |
| Z-1612-2018 | Class II | cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The... | Roche Diagnostics GmbH | CEM | |
| Z-1611-2018 | Class II | Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The... | Roche Diagnostics GmbH | CEM | |
| Z-1610-2018 | Class II | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche... | Roche Diagnostics GmbH | CEM | |
| Z-1785-2025 | Class II | True 3D Viewer, Model: EP-00003 | Echopixel, Inc. | LLZ | |
| Z-2134-2019 | Class II | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor... | Hycor Biomedical | DHR | |
| Z-1930-2018 | Class II | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1396-2018 | Class II | Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product... | Philips North America LLC | JAK | |
| Z-1518-2018 | Class III | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact... | CooperVision, Inc. | MVN | |
| Z-1517-2018 | Class III | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact... | CooperVision, Inc. | MVN | |
| Z-1516-2018 | Class III | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable... | CooperVision, Inc. | MVN | |
| Z-1515-2018 | Class III | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily... | CooperVision, Inc. | MVN |