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-0951-2022 | Class II | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) | Qiagen | OWD | |
| Z-0987-2022 | Class II | Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0986-2022 | Class II | Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0985-2022 | Class II | Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0866-2022 | Class II | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit | Gyn-Disposables, Inc. | OJH | |
| Z-0865-2022 | Class II | Anterior Hip Pack - Surgical Kit | Gyn-Disposables, Inc. | OJH | |
| Z-0864-2022 | Class II | Total Knee Pack - Surgical Kit | Gyn-Disposables, Inc. | OJH | |
| Z-0863-2022 | Class II | Lum Lam Custom Pack - Anesthesia Kit | Gyn-Disposables, Inc. | OFQ | |
| Z-0862-2022 | Class II | Surgicare Neuro Pack - Neurological Kit | Gyn-Disposables, Inc. | OJG | |
| Z-0784-2022 | Class II | Mycoplasma genitalium Control Panel (Inactivated Pellet) | Microbiologics, Inc. | OHQ | |
| Z-0948-2022 | Class II | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100... | Baxter Healthcare Corporation | KYX | |
| Z-0733-2022 | Class II | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0... | Brainlab, Inc. | IYE | |
| Z-0731-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Celltrion USA Inc | QKP | |
| Z-0831-2022 | Class II | MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484 | Baxter Healthcare Corporation | KDJ | |
| Z-1003-2022 | Class II | SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior... | Boston Scientific Corporation | OVB | |
| Z-1002-2022 | Class II | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily... | Boston Scientific Corporation | OVB | |
| Z-1120-2022 | Class II | Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R... | International Science and Technology, LP | HNN | |
| Z-0837-2022 | Class III | Regard Custom Procedure Kits containing BD Luer Lok Access Devices | ROi CPS LLC | LRS | |
| Z-0980-2022 | Class II | Artis Q.zen biplane, Model Number 10848355 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0979-2022 | Class II | Artis Q.zen ceiling, Model Number 10848354 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0978-2022 | Class II | Artis Q.zen floor, Model Number 10848353 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0977-2022 | Class II | Artis Q zeego, Model Number 10848283 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0976-2022 | Class II | Artis Q biplane, Model Number 10848282 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0975-2022 | Class II | Artis Q ceiling, Model Number 10848281 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0974-2022 | Class II | Artis Q floor, Model Number 10848280 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0973-2022 | Class II | Artis zeego, Model Number 10280959 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0972-2022 | Class II | Artis zee biplane MN, Model Number 10094143 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0971-2022 | Class II | Artis zee floor MN, Model Number 10094142 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0970-2022 | Class II | Artis zee biplane, Model Number 10094141 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0969-2022 | Class II | Artis zee multi-purpose, Model Number 10094139 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0968-2022 | Class II | Artis zee ceiling, Model Number 10094137 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0967-2022 | Class II | Artis zee floor, Model Number 10094135 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0833-2022 | Class II | (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5... | Medtronic, Inc. | HET | |
| Z-1204-2022 | Class II | SS 4.5MM Pellet Insertion Tray Catalog Number: B9807 | Busse Hospital Disposables | FBQ | |
| Z-1203-2022 | Class II | 3.2MM Pellet Insertion Tray Catalog Number: B9743 | Busse Hospital Disposables | FBQ | |
| Z-1202-2022 | Class II | Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1 | Busse Hospital Disposables | FBQ | |
| Z-1201-2022 | Class II | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1 | Busse Hospital Disposables | FBQ | |
| Z-1200-2022 | Class II | SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 | Busse Hospital Disposables | FBQ | |
| Z-1199-2022 | Class II | 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1 | Busse Hospital Disposables | FBQ | |
| Z-1198-2022 | Class II | SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1 | Busse Hospital Disposables | FBQ | |
| Z-1197-2022 | Class II | 3.2MM Pellet Insertion Tray Catalog Number: B7345R1 | Busse Hospital Disposables | FBQ | |
| Z-1196-2022 | Class II | Pellet Insertion Tray Catalog Number: B1654 | Busse Hospital Disposables | FBQ | |
| Z-1195-2022 | Class II | Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570 | Busse Hospital Disposables | FBQ | |
| Z-1194-2022 | Class II | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 | Busse Hospital Disposables | FBQ | |
| Z-1193-2022 | Class II | SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 | Busse Hospital Disposables | FBQ | |
| Z-1192-2022 | Class II | SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559 | Busse Hospital Disposables | FBR | |
| Z-1191-2022 | Class II | SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555 | Busse Hospital Disposables | FBQ | |
| Z-1190-2022 | Class II | SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547 | Busse Hospital Disposables | FBQ | |
| Z-1189-2022 | Class II | SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1 | Busse Hospital Disposables | FBQ | |
| Z-1188-2022 | Class II | SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1 | Busse Hospital Disposables | FBQ |