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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 721 of 1191

FDA device recalls, page 721 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0676-2014	Class II	13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer...	Abbott Medical	FPA	2013-12-24
Z-0675-2014	Class II	87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4...	Abbott Medical	FPA	2013-12-24
Z-0674-2014	Class II	10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000...	Abbott Medical	FPA	2013-12-24
Z-0673-2014	Class II	8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000...	Abbott Medical	FPA	2013-12-24
Z-0672-2014	Class II	8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock...	Abbott Medical	FPA	2013-12-24
Z-0671-2014	Class II	11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer...	Abbott Medical	FPA	2013-12-24
Z-0670-2014	Class II	78" Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave...	Abbott Medical	FPA	2013-12-24
Z-0669-2014	Class II	8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter...	Abbott Medical	FPA	2013-12-24
Z-0668-2014	Class II	7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector...	Abbott Medical	FPA	2013-12-24
Z-0667-2014	Class II	7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating...	Abbott Medical	FPA	2013-12-24
Z-0666-2014	Class II	6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer...	Abbott Medical	FPA	2013-12-24
Z-0665-2014	Class II	17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No...	Abbott Medical	FPA	2013-12-24
Z-0664-2014	Class II	NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a...	Abbott Medical	FPA	2013-12-24
Z-0663-2014	Class II	31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves...	Abbott Medical	FPA	2013-12-24
Z-0662-2014	Class II	184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron...	Abbott Medical	FPA	2013-12-24
Z-0661-2014	Class II	183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4...	Abbott Medical	FPA	2013-12-24
Z-0660-2014	Class II	6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3 Clamps, Rotating...	Abbott Medical	FPA	2013-12-24
Z-0659-2014	Class II	6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip...	Abbott Medical	FPA	2013-12-24
Z-0658-2014	Class II	NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001...	Abbott Medical	FPA	2013-12-24
Z-0976-2014	Class II	Horizon Medical Imaging, Picture Archive Communication System (PACS).	Mckesson Information Solutions, LLC	LLZ	2013-12-23
Z-0989-2014	Class II	Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system...	Aesculap Inc	JXG	2013-12-23
Z-0825-2014	Class II	ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA...	Siemens Medical Solutions USA, Inc.	IYN	2013-12-22
Z-0824-2014	Class II	ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60...	Siemens Medical Solutions USA, Inc.	IYN	2013-12-22
Z-1532-2014	Class II	IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188...	Siemens Healthcare Diagnostics Inc.	CIZ	2013-12-20
Z-1518-2014	Class II	IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and...	Siemens Healthcare Diagnostics Inc.	JHR	2013-12-20
Z-1531-2014	Class II	IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158...	Siemens Healthcare Diagnostics Inc.	CIZ	2013-12-20
Z-1517-2014	Class II	IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens...	Siemens Healthcare Diagnostics Inc.	JHR	2013-12-20
Z-0799-2014	Class II	Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all...	Carl Zeiss Microscopy, LLC	IBJ	2013-12-20
Z-0990-2014	Class II	Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit...	L. Perrigo Company	FKB	2013-12-20
Z-0649-2014	Class II	Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser...	OptiMedica Corp.	OOE	2013-12-20
Z-0927-2014	Class II	CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in...	GE Healthcare	MHX	2013-12-20
Z-1745-2014	Class II	Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance...	Philips North America LLC	JAK	2013-12-19
Z-1166-2014	Class II	VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH...	STERIS Corporation	JOJ	2013-12-19
Z-1074-2014	Class II	Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT...	Philips North America LLC	KPS	2013-12-19
Z-0871-2014	Class II	ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended...	GE Healthcare	MHX	2013-12-19
Z-0937-2014	Class II	Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test...	Accriva Diagnostics, Inc.	GFO	2013-12-19
Z-0784-2014	Class II	Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.	Zimmer GmbH	KRO	2013-12-19
Z-0716-2014	Class II	Locking Cortical Screw 3.5mmX38mm REF 8161-35-038	Zimmer GmbH	HRS	2013-12-19
Z-0647-2014	Class II	On Site Gas Systems POGS 33C Portable Oxygen Generation System	On Site Gas Systems Inc.	CAW	2013-12-19
Z-0771-2014	Class II	Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet...	Teleflex Medical	GEI	2013-12-19
Z-0770-2014	Class II	Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet...	Teleflex Medical	GEI	2013-12-19
Z-0783-2014	Class II	Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant...	Zimmer GmbH	KRO	2013-12-19
Z-0096-2018	Class II	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled...	Zimmer GmbH	HAW	2013-12-18
Z-1086-2014	Class II	Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part...	Howmedica Osteonics Corp	LXH	2013-12-18
Z-0901-2014	Class II	Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a...	Merit Medical Systems, Inc.	BWN	2013-12-18
Z-0712-2014	Class II	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN...	Boston Scientific Corporation		2013-12-18
Z-0711-2014	Class II	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN...	Boston Scientific Corporation	FGE	2013-12-18
Z-0710-2014	Class II	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN...	Boston Scientific Corporation	FGE	2013-12-18
Z-0930-2014	Class II	ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro...	Siemens Healthcare Diagnostics Inc.	DIP	2013-12-18
Z-0924-2014	Class III	ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and...	Horiba Instruments Incorporated	JJY	2013-12-18