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-2376-2020 | Class II | Stryker End Cap, Standard T2 Humerus 6 mm Catalog Number: 18300003S - Product Usage... | Stryker Corp. | HSB | |
| Z-2375-2020 | Class II | Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker... | Stryker Corp. | HSB | |
| Z-2374-2020 | Class II | Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage... | Stryker Corp. | HSB | |
| Z-2373-2020 | Class II | Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product... | Stryker Corp. | HSB | |
| Z-2263-2020 | Class I | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I... | Endologix LLC | MIH | |
| Z-2234-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2233-2020 | Class II | Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055... | Zimmer GmbH | LXH | |
| Z-2232-2020 | Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560... | Zimmer GmbH | NKB | |
| Z-2231-2020 | Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555... | Zimmer GmbH | NKB | |
| Z-2230-2020 | Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550... | Zimmer GmbH | NKB | |
| Z-2229-2020 | Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545... | Zimmer GmbH | NKB | |
| Z-2228-2020 | Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540... | Zimmer GmbH | NKB | |
| Z-2227-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2226-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2225-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2224-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2223-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2222-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2221-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2220-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2219-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2218-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2217-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2216-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2215-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2214-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2292-2020 | Class II | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal... | OLYMPUS Corporation of the Americas | EOB | |
| Z-2213-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2212-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2211-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2210-2020 | Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number... | Zimmer GmbH | NKB | |
| Z-2398-2020 | Class II | BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated... | Boston Scientific Corporation | LJS | |
| Z-2397-2020 | Class II | BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or... | Boston Scientific Corporation | LJS | |
| Z-2396-2020 | Class II | BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the... | Boston Scientific Corporation | FOZ | |
| Z-2285-2020 | Class II | Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2284-2020 | Class II | Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2283-2020 | Class II | Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2282-2020 | Class II | ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number... | Siemens Healthcare Diagnostics Inc. | JFY | |
| Z-2281-2020 | Class II | Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number... | Siemens Healthcare Diagnostics Inc. | LCP | |
| Z-2280-2020 | Class II | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number... | Siemens Healthcare Diagnostics Inc. | LCP | |
| Z-2369-2020 | Class II | Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes... | Resource Optimization & Innovation, LLC | PEZ | |
| Z-2368-2020 | Class II | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush... | Resource Optimization & Innovation, LLC | OFF | |
| Z-2395-2020 | Class II | BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These... | Boston Scientific Corporation | FOZ | |
| Z-2205-2020 | Class II | AC Powered hospital adjustable bed. | Umano Medical Inc. | FNL | |
| Z-2363-2020 | Class II | Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 | Zimmer GmbH | N/A | |
| Z-2362-2020 | Class II | Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 | Zimmer GmbH | LXH | |
| Z-0518-2021 | Class II | MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product... | Medtronic, Inc. | N/A | |
| Z-0517-2021 | Class II | MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K... | Medtronic, Inc. | OZO | |
| Z-0516-2021 | Class II | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product... | Medtronic, Inc. | OZP | |
| Z-2402-2020 | Class II | Diasol 1000225-10-Dex100 Liquid Acid Concentrate for Bicarbonate Dialysis | Diasol, Inc | KPO |