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-2312-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FDE | |
| Z-2311-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FCM | |
| Z-2310-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | FCH | |
| Z-2309-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OGR | |
| Z-2308-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFX | |
| Z-2307-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFG | |
| Z-2306-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-2305-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-2304-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFD | |
| Z-2303-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-2302-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-2301-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-2278-2023 | Class II | OEC Elite Systems with 9-inch Image Intensifier | GE Healthcare | OWB | |
| Z-2300-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-2299-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-2277-2023 | Class II | OEC 9900 Systems with 9-inch Image Intensifier | GE Healthcare | OXO | |
| Z-2276-2023 | Class II | OEC 9800 Systems with 9-inch Image Intensifier | GE Healthcare | OWB | |
| Z-2275-2023 | Class II | OEC Flexiview 8800 Systems with 9-inch Image Intensifier | GE Healthcare | OXO | |
| Z-2093-2023 | Class III | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA... | Neumodx Molecular, Inc. | QJR | |
| Z-2298-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-2297-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OES | |
| Z-2296-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OEQ | |
| Z-2295-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OGJ | |
| Z-2294-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OGD | |
| Z-2293-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | OFT | |
| Z-2292-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | CBT | |
| Z-2025-2023 | Class II | Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient... | DRE Med | MNT | |
| Z-2291-2023 | Class II | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel... | MEDLINE INDUSTRIES, LP - Northfield | CAI | |
| Z-2290-2023 | Class II | Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following... | MEDLINE INDUSTRIES, LP - Northfield | MMP | |
| Z-2269-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2268-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2267-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2266-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2265-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2264-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2263-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2262-2023 | Class II | Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm... | OLYMPUS Corporation of the Americas | JAK | |
| Z-2206-2023 | Class II | Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 | MEDLINE INDUSTRIES, LP - Northfield | HRR | |
| Z-2058-2023 | Class II | Trackmaster, Treadmill Ge T2100-St2 220V China, Model Number 317-07927Ge China | Full Vision Inc | IOL | |
| Z-2057-2023 | Class II | Trackmaster, Treadmill Ge T2100-St2 220V, Model Number 317-07927Ge | Full Vision Inc | IOL | |
| Z-2056-2023 | Class II | Trackmaster, Treadmill Ge T2100-St1 110Vv, Model Number 317-07926Ge | Full Vision Inc | IOL | |
| Z-2055-2023 | Class II | Trackmaster, Treadmill Tmx428cp 220V, Model Number 317-07929 | Full Vision Inc | IOL | |
| Z-2054-2023 | Class II | Trackmaster, Treadmill Tmx428cp 110V, Model Number 317-07928 | Full Vision Inc | IOL | |
| Z-2053-2023 | Class II | Trackmaster, Treadmill Tmx428 220V, Model Number 317-07927 | Full Vision Inc | IOL | |
| Z-2052-2023 | Class II | Trackmaster, Treadmill Tmx428 110V, Model Number 317-07926 | Full Vision Inc | IOL | |
| Z-1906-2023 | Class II | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621... | Ossur Iceland ehf. | ISH | |
| Z-1972-2023 | Class II | Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800... | Boston Scientific Neuromodulation Corporation | NQO | |
| Z-1283-2024 | Class II | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 | Fresenius Kabi USA, LLC | FRN | |
| Z-1823-2023 | Class I | ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1822-2023 | Class I | ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS |