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-1979-2021 | Class II | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket... | Philips North America LLC | JAK | |
| Z-2012-2021 | Class III | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin... | Sentinel CH SpA | JJX | |
| Z-1794-2021 | Class II | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part... | Wishbone Medical, Inc. | HRS | |
| Z-1775-2021 | Class II | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse... | FUJIFILM Healthcare Americas Corporation | LLZ | |
| Z-2049-2021 | Class II | Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length... | RAND S.p.A. | LGZ | |
| Z-2048-2021 | Class II | Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 | RAND S.p.A. | LGZ | |
| Z-1847-2021 | Class II | CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable... | CooperSurgical, Inc. | GEI | |
| Z-1841-2021 | Class II | Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile... | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-1840-2021 | Class II | Myriad-LX Light Source-for delivery of light to the surgical field to enhance... | Nico Corporation | GEI | |
| Z-1839-2021 | Class II | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF... | Nico Corporation | GEI | |
| Z-1924-2021 | Class II | Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1923-2021 | Class II | Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1922-2021 | Class II | Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1921-2021 | Class II | Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1920-2021 | Class II | Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1919-2021 | Class II | Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1918-2021 | Class II | Hays Ultrasound kit Item ID: H1000SE | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1917-2021 | Class II | Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1916-2021 | Class II | Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1895-2021 | Class II | Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1894-2021 | Class II | Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1893-2021 | Class II | Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1892-2021 | Class II | Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1891-2021 | Class II | Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1890-2021 | Class II | Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1889-2021 | Class II | Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion... | Medtronic Perfusion Systems | DWF | |
| Z-1888-2021 | Class II | Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1887-2021 | Class II | Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1886-2021 | Class II | Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1915-2021 | Class II | Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1914-2021 | Class II | Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1913-2021 | Class II | Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1912-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1911-2021 | Class II | Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1910-2021 | Class II | 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1909-2021 | Class II | 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1908-2021 | Class II | Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1907-2021 | Class II | Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk... | Exact Medical Manufacturing, Inc. | ITX | |
| Z-1885-2021 | Class II | Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile... | Medtronic Perfusion Systems | DWF | |
| Z-1884-2021 | Class II | Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1883-2021 | Class II | Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System, | Medtronic Perfusion Systems | DWF | |
| Z-1882-2021 | Class II | Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1881-2021 | Class II | Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1880-2021 | Class II | Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1879-2021 | Class II | Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile... | Medtronic Perfusion Systems | DWF | |
| Z-1878-2021 | Class II | Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1877-2021 | Class II | Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System... | Medtronic Perfusion Systems | DWF | |
| Z-1876-2021 | Class II | Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1875-2021 | Class II | Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF | |
| Z-1874-2021 | Class II | Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx. | Medtronic Perfusion Systems | DWF |