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-0663-2022 | Class I | Philips Respironics V60 Plus Ventilator Part Number 1138747 | Respironics, Inc. | MNT | |
| Z-0662-2022 | Class I | Philips Respironics V60 Ventilator Part Number 1053617 | Respironics, Inc. | MNT | |
| Z-0563-2022 | Class II | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | Argon Medical Devices, Inc | GDY | |
| Z-0738-2022 | Class II | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under... | Neumodx Molecular, Inc. | QJR | |
| Z-0818-2022 | Class II | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an... | Integra LifeSciences Corporation | OJG | |
| Z-0817-2022 | Class II | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an... | Integra LifeSciences Corporation | OJG | |
| Z-0664-2022 | Class II | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single... | Stryker Sustainability Solutions | KCY | |
| Z-0526-2022 | Class II | 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support... | NRT X-Ray a/S | OWB | |
| Z-1853-2022 | Class II | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic... | Surgical Innovations Ltd | GCJ | |
| Z-1852-2022 | Class II | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite... | Surgical Innovations Ltd | GCJ | |
| Z-1284-2022 | Class II | QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A... | Microgenics Corporation | MLM | |
| Z-0894-2022 | Class II | BenchMark ULTRA and DISCOVERY ULTRA Instruments | Ventana Medical Systems Inc | KPA | |
| Z-0963-2022 | Class II | The Sight OLO device is a computer vision based platform for blood analysis. The... | Sight Diagnostics, Ltd. | GKZ | |
| Z-0813-2022 | Class II | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Outset Medical, Inc. | KDI | |
| Z-0800-2022 | Class II | Safe-T Plus Atraumatic Adult Lp Tray | Bard Peripheral Vascular Inc | PWY | |
| Z-0799-2022 | Class II | Lumbar Puncture Drug Free Tray 22G | Bard Peripheral Vascular Inc | PWY | |
| Z-0798-2022 | Class II | Atraumatic Adult Lumbar Puncture Tray | Bard Peripheral Vascular Inc | PWY | |
| Z-0797-2022 | Class II | Safe-T Plus Lumbarpuncture Tray Adult | Bard Peripheral Vascular Inc | PWY | |
| Z-0796-2022 | Class II | Lumbar Puncture Tray Adult 22G X3.5 Strl | Bard Peripheral Vascular Inc | PWY | |
| Z-0795-2022 | Class II | Lumbar Puncture Tray Adult 18G X 3.5 | Bard Peripheral Vascular Inc | PWY | |
| Z-0794-2022 | Class II | Safe-T Plus Lumbar Puncture Tray Adult | Bard Peripheral Vascular Inc | PWY | |
| Z-0793-2022 | Class II | Adult Lumbar Puncture Drug Free Tray 20G | Bard Peripheral Vascular Inc | PWY | |
| Z-0792-2022 | Class II | Lumbar Puncture Tray Adult 20G X 3.5 Dp | Bard Peripheral Vascular Inc | PWY | |
| Z-0791-2022 | Class II | Lumbar Puncture Tray Pediatric 21G 2.5 | Bard Peripheral Vascular Inc | PWY | |
| Z-0790-2022 | Class II | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with... | Bard Peripheral Vascular Inc | PWY | |
| Z-0746-2022 | Class II | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial... | Envisiontec US LLC | EBZ | |
| Z-0885-2022 | Class II | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x | Volcano Corporation | OWB | |
| Z-0748-2022 | Class II | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0741-2022 | Class II | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome... | Cytocell Limited | QDI | |
| Z-0650-2022 | Class II | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Merete GmbH | JDR | |
| Z-0782-2022 | Class II | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | MXD | |
| Z-0709-2022 | Class II | Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye... | Lacrimedics, Inc. | LZU | |
| Z-0708-2022 | Class II | OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx... | Lacrimedics, Inc. | LZU | |
| Z-0843-2022 | Class II | Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 | Howmedica Osteonics Corp | LZO | |
| Z-0842-2022 | Class II | Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 | Howmedica Osteonics Corp | LZO | |
| Z-0729-2022 | Class II | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60... | Maquet Cardiovascular LLC | MAL | |
| Z-0783-2022 | Class II | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead... | Hill-Rom Inc. | FSA | |
| Z-0723-2022 | Class II | CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex | Carl Zeiss Meditec Inc | OBO | |
| Z-0728-2022 | Class II | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy... | Stryker Corp. | GCJ | |
| Z-0720-2022 | Class II | BUTLER Clear Dip, 12 bottles/case | Sunstar Americas, Inc. | OCT | |
| Z-0740-2022 | Class II | Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone... | Medartis AG | HWC | |
| Z-0739-2022 | Class II | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone... | Medartis AG | HWC | |
| Z-0718-2022 | Class I | COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog... | Lusys Laboratories, Inc. | QKO | |
| Z-0717-2022 | Class I | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety... | Lusys Laboratories, Inc. | QKP | |
| Z-0716-2022 | Class I | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat... | Lusys Laboratories, Inc. | QKP | |
| Z-0745-2022 | Class III | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak | Physio Control, Inc. | MKJ | |
| Z-0706-2022 | Class II | Everest MI XT Outer Dilator, Catalog Number 5101-90168 | K2M, Inc | KWP | |
| Z-0705-2022 | Class II | Everest MI XT Inner Dilator, Catalog Number 5101-90167 | K2M, Inc | KWP | |
| Z-0693-2022 | Class II | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | ROi CPS LLC | OJH | |
| Z-0826-2022 | Class II | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 | Diagnos Inc | NFJ |