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-2095-2018 | Class II | ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic | Tosoh Bioscience Inc | CFL | |
| Z-2094-2018 | Class II | ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic | Tosoh Bioscience Inc | JFT | |
| Z-2093-2018 | Class II | ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CDZ | |
| Z-2092-2018 | Class II | ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CDZ | |
| Z-2091-2018 | Class II | ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone | Tosoh Bioscience Inc | JLS | |
| Z-2090-2018 | Class II | ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CEP | |
| Z-2089-2018 | Class II | ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CHP | |
| Z-2088-2018 | Class II | ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CHP | |
| Z-2087-2018 | Class II | ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CFT | |
| Z-2086-2018 | Class II | ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone | Tosoh Bioscience Inc | CGJ | |
| Z-2085-2018 | Class II | ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone | Tosoh Bioscience Inc | JKC | |
| Z-2084-2018 | Class II | ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone | Tosoh Bioscience Inc | DHA | |
| Z-2083-2018 | Class II | ST-AIA PACK HCG; Part Number: 025261 Assay, Reproductive Hormone | Tosoh Bioscience Inc | JHI | |
| Z-2082-2018 | Class II | ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid | Tosoh Bioscience Inc | KHQ | |
| Z-2081-2018 | Class II | ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid | Tosoh Bioscience Inc | CEC | |
| Z-2080-2018 | Class II | ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid | Tosoh Bioscience Inc | CDP | |
| Z-2079-2018 | Class II | ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid | Tosoh Bioscience Inc | KLI | |
| Z-2078-2018 | Class II | ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid | Tosoh Bioscience Inc | CDP | |
| Z-2077-2018 | Class II | AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid | Tosoh Bioscience Inc | JLW | |
| Z-2076-2018 | Class II | ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes | Tosoh Bioscience Inc | CFP | |
| Z-2075-2018 | Class II | ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes | Tosoh Bioscience Inc | JKD | |
| Z-2074-2018 | Class II | ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes | Tosoh Bioscience Inc | JKD | |
| Z-2073-2018 | Class II | ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker | Tosoh Bioscience Inc | MMI | |
| Z-2072-2018 | Class II | ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker | Tosoh Bioscience Inc | DDR | |
| Z-2071-2018 | Class II | ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker | Tosoh Bioscience Inc | JHX | |
| Z-2070-2018 | Class II | ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker | Tosoh Bioscience Inc | MOI | |
| Z-2069-2018 | Class II | ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker | Tosoh Bioscience Inc | NIG | |
| Z-2068-2018 | Class II | ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate | Tosoh Bioscience Inc | JFH | |
| Z-2067-2018 | Class II | ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker | Tosoh Bioscience Inc | LTJ | |
| Z-2066-2018 | Class II | ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker | Tosoh Bioscience Inc | DHX | |
| Z-2065-2018 | Class II | ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker | Tosoh Bioscience Inc | LOJ | |
| Z-1511-2018 | Class II | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally... | Synthes GmbH | LXH | |
| Z-2247-2018 | Class II | Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set | Synthes (USA) Products LLC | FSM | |
| Z-2246-2018 | Class II | Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set | Synthes (USA) Products LLC | FSM | |
| Z-2245-2018 | Class II | Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Synthes (USA) Products LLC | FSM | |
| Z-1812-2018 | Class II | Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN... | Tosoh Bioscience Inc | N/A | |
| Z-1811-2018 | Class II | Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In... | Tosoh Bioscience Inc | JJY | |
| Z-1810-2018 | Class II | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended... | Tosoh Bioscience Inc | JIT | |
| Z-1809-2018 | Class II | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In... | Tosoh Bioscience Inc | LCP | |
| Z-1200-2018 | Class II | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-1545-2018 | Class III | BD MAX DNA MMK Lab Use, catalog no. 442828 | Becton Dickinson & Co | PPM | |
| Z-1544-2018 | Class III | BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 | Becton Dickinson & Co | PPM | |
| Z-1631-2018 | Class II | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN... | Randox Laboratories, Limited | CDT | |
| Z-1380-2018 | Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info... | Getinge Disinfection AB | MEC | |
| Z-1379-2018 | Class II | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86... | Getinge Disinfection AB | MEC | |
| Z-1643-2018 | Class II | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1362-2018 | Class II | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-2816-2018 | Class II | 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. | ICU MEDICAL de MEXICO, S. de R.L. de C.V. | FMG | |
| Z-2815-2018 | Class II | 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow... | ICU MEDICAL de MEXICO, S. de R.L. de C.V. | FMG | |
| Z-2814-2018 | Class II | 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp... | ICU MEDICAL de MEXICO, S. de R.L. de C.V. | FMG |