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-0049-2017 | Class II | Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner | Canon Medical Systems USA, Inc. | KPS | |
| Z-0048-2017 | Class II | Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner | Canon Medical Systems USA, Inc. | JAK | |
| Z-0047-2017 | Class II | Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT... | Canon Medical Systems USA, Inc. | JAK | |
| Z-0046-2017 | Class II | Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. | Canon Medical Systems USA, Inc. | JAK | |
| Z-2000-2016 | Class II | BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1999-2016 | Class II | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1998-2016 | Class II | Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1997-2016 | Class II | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2148-2016 | Class III | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) | Haleon US HOLDINGS LLC | N/A | |
| Z-1813-2016 | Class II | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software... | Volcano Corporation | OBJ | |
| Z-1607-2016 | Class II | Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B... | Canon Medical Systems USA, Inc. | KPS | |
| Z-1093-2017 | Class II | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes | Neogen Culture Media | JSG | |
| Z-2037-2016 | Class II | Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2036-2016 | Class II | SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2035-2016 | Class II | SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2034-2016 | Class II | Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2033-2016 | Class II | Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2032-2016 | Class II | Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2031-2016 | Class II | Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2030-2016 | Class II | Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2029-2016 | Class II | BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2028-2016 | Class II | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2027-2016 | Class II | BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2026-2016 | Class II | BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2025-2016 | Class II | BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2024-2016 | Class II | BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2023-2016 | Class II | BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2022-2016 | Class II | BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2021-2016 | Class II | BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2020-2016 | Class II | BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2019-2016 | Class II | BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2018-2016 | Class II | BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2017-2016 | Class II | Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2016-2016 | Class II | BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2015-2016 | Class II | BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2014-2016 | Class II | BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2013-2016 | Class II | BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2012-2016 | Class II | BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2011-2016 | Class II | Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2010-2016 | Class II | BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2009-2016 | Class II | BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2008-2016 | Class II | BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2007-2016 | Class II | BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2006-2016 | Class II | Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-2005-2016 | Class II | Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are... | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-1963-2016 | Class II | BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF | |
| Z-1962-2016 | Class II | BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF | |
| Z-1961-2016 | Class II | BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF | |
| Z-1960-2016 | Class II | BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF | |
| Z-1959-2016 | Class II | BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone... | Arthrex GmbH | PLF |