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-2967-2018 | Class II | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component... | Encore Medical, LP | JWH | |
| Z-2885-2018 | Class II | O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | O-Two Medical Technologies, Inc. | BZR | |
| Z-2342-2018 | Class II | Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab... | Becton Dickinson & Co | EMF | |
| Z-2439-2018 | Class II | AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF... | Opgen Inc | LJG | |
| Z-2272-2018 | Class II | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 | Artivion, Inc. | DXZ | |
| Z-2271-2018 | Class II | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | Artivion, Inc. | OHA | |
| Z-2161-2018 | Class II | Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part... | MAQUET CARDIOPULMONARY GmbH | DWF | |
| Z-2160-2018 | Class II | Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part... | MAQUET CARDIOPULMONARY GmbH | DWF | |
| Z-2159-2018 | Class II | Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part... | MAQUET CARDIOPULMONARY GmbH | DWF | |
| Z-2336-2018 | Class II | Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-2183-2018 | Class II | Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee... | Zimmer GmbH | JWH | |
| Z-2268-2018 | Class II | Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b)... | Smith & Nephew, Inc. | NXT | |
| Z-2267-2018 | Class II | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF... | Smith & Nephew, Inc. | NXT | |
| Z-1945-2018 | Class II | Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated... | Olsen Medical | GEI | |
| Z-1944-2018 | Class II | Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm)... | Olsen Medical | GEI | |
| Z-1943-2018 | Class II | Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10'... | Olsen Medical | GEI | |
| Z-1942-2018 | Class II | Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument... | Olsen Medical | GEI | |
| Z-1941-2018 | Class II | Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF... | Olsen Medical | GEI | |
| Z-2270-2018 | Class II | Olympus JF-160F duodenoscopes (Model NumberJF-160F) | OLYMPUS Corporation of the Americas | FET | |
| Z-2269-2018 | Class II | Olympus JF-140F duodenoscopes (Model NumberJF-140F) | OLYMPUS Corporation of the Americas | FET | |
| Z-0155-2022 | Class II | medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c... | Abbott Medical | FMG | |
| Z-2963-2018 | Class II | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm... | ZimVie US Corp LLC | DZE | |
| Z-2794-2018 | Class II | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee... | Mako Surgical Corp. | OLO | |
| Z-2547-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number... | Life Technologies Corporation | NDS | |
| Z-2546-2018 | Class II | Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium. | Life Technologies Corporation | NDS | |
| Z-2545-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175... | Life Technologies Corporation | NDS | |
| Z-2544-2018 | Class II | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number... | Life Technologies Corporation | NDS | |
| Z-2543-2018 | Class II | GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture... | Life Technologies Corporation | NDS | |
| Z-2542-2018 | Class II | Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503... | Life Technologies Corporation | NDS | |
| Z-2423-2018 | Class II | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix... | Anika Therapeutics, Inc. | FRO | |
| Z-2225-2018 | Class II | RS 5F DL XCELA PICC, Catalog Number 60M122272 | Boston Scientific Corporation | LJS | |
| Z-2224-2018 | Class II | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG... | Boston Scientific Corporation | LJS | |
| Z-2223-2018 | Class II | BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog... | Boston Scientific Corporation | LJS | |
| Z-2222-2018 | Class II | BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog... | Boston Scientific Corporation | LJS | |
| Z-2221-2018 | Class II | BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019 | Boston Scientific Corporation | LJS | |
| Z-2220-2018 | Class II | Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003 | Boston Scientific Corporation | LJS | |
| Z-2219-2018 | Class II | CAN 5F DUAL XCELA PICC, Catalog Number 60M701532 | Boston Scientific Corporation | LJS | |
| Z-2218-2018 | Class II | CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531 | Boston Scientific Corporation | LJS | |
| Z-2217-2018 | Class II | CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936 | Boston Scientific Corporation | LJS | |
| Z-2216-2018 | Class II | RS TANDEM 5F DL BIOFLO PICC, Catalog Number 60M250097 | Boston Scientific Corporation | LJS | |
| Z-2215-2018 | Class II | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242 | Boston Scientific Corporation | LJS | |
| Z-2214-2018 | Class II | RS 5F DL BIOFLO PASV, Catalog Number 60M183481 | Boston Scientific Corporation | LJS | |
| Z-2213-2018 | Class II | RS 5F DL XPP KIT, Catalog Number 60M183104 | Boston Scientific Corporation | LJS | |
| Z-2212-2018 | Class II | RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 | Boston Scientific Corporation | LJS | |
| Z-2211-2018 | Class II | RS 5F DL BIOFLO PASV, Catalog Number 60M181578 | Boston Scientific Corporation | LJS | |
| Z-2210-2018 | Class II | 5F DL BIOFLO PICC, Catalog Number 60M180592 | Boston Scientific Corporation | LJS | |
| Z-2209-2018 | Class II | RS 5F DL BIOFLO PASV, Catalog Number 60M161567 | Boston Scientific Corporation | LJS | |
| Z-2208-2018 | Class II | RS 5F DL BIOFLO PASV, Catalog Number 60M150373 | Boston Scientific Corporation | LJS | |
| Z-2207-2018 | Class II | 5F DL BIOFLO PASV, Catalog Number 60M141006 | Boston Scientific Corporation | LJS | |
| Z-2206-2018 | Class II | TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567 | Boston Scientific Corporation | LJS |