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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 530 of 1191

FDA device recalls, page 530 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1902-2017	Class II	Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as...	Breg Inc	KGX	2017-03-30
Z-1901-2017	Class II	Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used...	Breg Inc	KGX	2017-03-30
Z-1875-2017	Class II	18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A...	Siemens Medical Solutions USA, Inc.	IYN	2017-03-30
Z-2053-2017	Class I	HeartMate II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI...	Abbott Medical	DSQ	2017-03-30
Z-2052-2017	Class I	HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI...	Abbott Medical	DSQ	2017-03-30
Z-2051-2017	Class I	HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL...	Abbott Medical	DSQ	2017-03-30
Z-1920-2017	Class II	Renovation, Rounded End, Thin Osteotome Blade, 20 Mm, Ref 71369420, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1919-2017	Class II	Renovation, Rounded End, Thin Osteotome Blade, 12 Mm, Ref 71369412, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1918-2017	Class II	Renovation, Thin Osteotome Blade, 10 Mm X 3 Inch, Ref 71369410, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1917-2017	Class II	Renovation, Thin Osteotome Blade, 8 Mm X 5 Inch, Ref 71369408, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1916-2017	Class II	Renovation, Thin Osteotome Blade, 20 Mm X 3 Inch, Ref 71369220, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1915-2017	Class II	Renovation, Thin Osteotome Blade, 12 Mm X 3 Inch, Ref 71369212, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1914-2017	Class II	Renovation, Thin Osteotome Blade, 10 Mm X 3 Inch, Ref 71369210, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1913-2017	Class II	Renovation, Thin Osteotome Blade, 8 Mm X 3 Inch, Ref 71369208, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1912-2017	Class II	Renovation, Radial Osteotome Blade, Size 16, Ref 71369316, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1911-2017	Class II	Renovation, Radial Osteotome Blade, Size 14, Ref 71369314, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1910-2017	Class II	Renovation, Radial Osteotome Blade, Size 12, Ref 71369312, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1909-2017	Class II	Renovation, Radial Osteotome Blade, Size 10, Ref 71369310, Sterile R, Qty: (1)	Smith & Nephew, Inc.	KDG	2017-03-30
Z-1874-2017	Class I	Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport...	Newport Medical Instruments, Inc.	CBK	2017-03-30
Z-2058-2017	Class II	Medi-Therm Hyper/Hypothermia System, MTA7900	Stryker Medical	DWJ	2017-03-29
Z-1776-2017	Class II	Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number...	Volcano Corporation	OBJ	2017-03-29
Z-1775-2017	Class II	Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number...	Volcano Corporation	OBJ	2017-03-29
Z-1829-2017	Class III	Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.	Teleflex Medical	FMI	2017-03-29
Z-2089-2017	Class II	GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR...	Aesculap Inc	GEY	2017-03-28
Z-2088-2017	Class II	GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR...	Aesculap Inc	GEY	2017-03-28
Z-2087-2017	Class II	GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+...	Aesculap Inc	GEY	2017-03-28
Z-1867-2017	Class II	216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model...	Mizuho Orthopedic Systems Inc	FWZ	2017-03-28
Z-1900-2017	Class II	MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product...	Bard Peripheral Vascular Inc	GDF	2017-03-28
Z-1774-2017	Class II	Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus...	Draeger Medical Systems, Inc.	MHX	2017-03-28
Z-1824-2017	Class II	Artis zee, Angiographic x-ray system	Siemens Medical Solutions USA, Inc.	IZI	2017-03-28
Z-1773-2017	Class II	Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi...	Draeger Medical Systems, Inc.	MHX	2017-03-28
Z-1772-2017	Class II	Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus...	Draeger Medical Systems, Inc.	MHX	2017-03-28
Z-2070-2017	Class II	Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product...	Mentor	FWM	2017-03-27
Z-1837-2017	Class II	Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use...	Alcon Laboratories	PAX	2017-03-27
Z-1500-2022	Class II	Legacy Base for Dual Bed Configurations	Craftmatic Industries, Inc.	LLI	2017-03-24
Z-1499-2022	Class II	Craftmatic Model 1 Base for Dual Bed Configurations	Craftmatic Industries, Inc.	LLI	2017-03-24
Z-2108-2017	Class II	WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is...	Teleflex Medical	GDT	2017-03-24
Z-1928-2017	Class II	Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock...	Dale Medical Products, Inc.	CBH	2017-03-24
Z-2046-2017	Class II	Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching	Arthrex GmbH	MAI	2017-03-24
Z-2045-2017	Class II	Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm	Arthrex GmbH	MAI	2017-03-24
Z-2044-2017	Class II	Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching	Arthrex GmbH	MAI	2017-03-24
Z-2043-2017	Class II	Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching	Arthrex GmbH	MAI	2017-03-24
Z-2042-2017	Class II	Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching	Arthrex GmbH	MAI	2017-03-24
Z-2041-2017	Class II	Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching	Arthrex GmbH	MAI	2017-03-24
Z-1927-2017	Class II	Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock...	Dale Medical Products, Inc.	CBH	2017-03-24
Z-1888-2017	Class II	Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS...	Remel Inc	JSH	2017-03-24
Z-3111-2017	Class II	Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use...	Canon Medical Systems USA, Inc.	MQB	2017-03-23
Z-2621-2017	Class II	Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory...	Omega Medical Imaging, LLC	IWE	2017-03-23
Z-1889-2017	Class II	1 mL Medallion Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P...	Merit Medical Systems, Inc.	FMF	2017-03-23
Z-2034-2017	Class II	Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1...	Sysmex America, Inc.	GKZ	2017-03-23