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-1815-2022 | Class II | Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number... | OLYMPUS Corporation of the Americas | GEI | |
| Z-1814-2022 | Class II | Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number... | OLYMPUS Corporation of the Americas | GEI | |
| Z-1813-2022 | Class II | Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number... | OLYMPUS Corporation of the Americas | GEI | |
| Z-1823-2022 | Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop... | CooperSurgical, Inc. | MQG | |
| Z-1822-2022 | Class II | Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop... | CooperSurgical, Inc. | MQG | |
| Z-1668-2022 | Class II | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors | DeRoyal Industries, Inc. | LRO | |
| Z-0182-2023 | Class II | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System... | Sedecal S.A. | IZL | |
| Z-1820-2022 | Class II | IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens... | Siemens Healthcare Diagnostics Inc. | JZO | |
| Z-1734-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | JDI | |
| Z-1733-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL... | Exactech, Inc. | JDI | |
| Z-1732-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | LZO | |
| Z-1731-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL... | Exactech, Inc. | LPH | |
| Z-1730-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | KWZ | |
| Z-1729-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | LZO | |
| Z-1728-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | LPH | |
| Z-1727-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | LPH | |
| Z-1726-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a... | Exactech, Inc. | MEH | |
| Z-1725-2022 | Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0... | Exactech, Inc. | KWZ | |
| Z-1819-2022 | Class II | VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box... | Boston Scientific Corporation | GEX | |
| Z-1647-2022 | Class II | Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1646-2022 | Class II | Artis pheno- Model No. 10849000 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1645-2022 | Class II | Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1736-2022 | Class III | Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam... | STERIS Corporation | JOJ | |
| Z-1684-2022 | Class II | Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02... | Saranas, Inc. | QFJ | |
| Z-0323-2023 | Class I | Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B | Dewei Medical Equipment Co Ltd | QBD | |
| Z-0001-2023 | Class I | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 | Jiangsu Well Biotech Co.,Ltd. | QKP | |
| Z-1582-2022 | Class II | Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 | Boston Scientific Corporation | DQY | |
| Z-1858-2022 | Class II | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate... | Hologic, Inc. | NEU | |
| Z-1737-2022 | Class II | Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25... | Technomed Europe | IKT | |
| Z-1653-2022 | Class I | Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403... | Baxter Healthcare Corporation | FPA | |
| Z-0324-2023 | Class II | CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-AD... | GS Biomark LLC | QJR | |
| Z-1773-2022 | Class II | PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm)... | Ethicon, Inc | NEW | |
| Z-1735-2022 | Class II | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako... | Mako Surgical Corp. | OLO | |
| Z-0131-2023 | Class II | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic... | Datascope Corp. | DSQ | |
| Z-1687-2022 | Class II | Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter | Datascope Corp. | DSP | |
| Z-1686-2022 | Class II | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter | Datascope Corp. | DSP | |
| Z-1685-2022 | Class II | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Datascope Corp. | DSP | |
| Z-0421-2023 | Class II | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead... | Integrity Implants, Inc. | NKB | |
| Z-0138-2023 | Class II | CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B... | Merit Medical Systems, Inc. | KNW | |
| Z-0137-2023 | Class II | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A... | Merit Medical Systems, Inc. | KNW | |
| Z-1777-2022 | Class II | Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed... | Collagen Matrix, Inc | KGN | |
| Z-0006-2023 | Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE... | Wright Medical Technology Inc | KWI | |
| Z-0005-2023 | Class II | stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE... | Wright Medical Technology Inc | KWI | |
| Z-1857-2022 | Class II | MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per... | MEDLINE INDUSTRIES, LP - Northfield | BSY | |
| Z-1856-2022 | Class II | MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA... | MEDLINE INDUSTRIES, LP - Northfield | BSY | |
| Z-1855-2022 | Class II | MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per... | MEDLINE INDUSTRIES, LP - Northfield | BSY | |
| Z-1747-2022 | Class II | FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm)... | Carwild Corp. | EFN | |
| Z-1661-2022 | Class II | The product is a handheld ultraviolet-C germicidal wand and contains two... | Merchsource LLC | RHP | |
| Z-1772-2022 | Class II | The Randox Serology I Positive Control contains the following analytes in human based... | Randox Laboratories, Limited | OHQ | |
| Z-1724-2022 | Class II | 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3... | Abbott Medical | FPA |