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 599 of 1191

FDA device recalls, page 599 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1353-2016	Class II	Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional...	Philips North America LLC	JAK	2016-02-05
Z-1352-2016	Class II	Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional...	Philips North America LLC	JAK	2016-02-05
Z-1351-2016	Class II	Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional...	Philips North America LLC	JAK	2016-02-05
Z-1185-2016	Class II	Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher	Stryker Medical	FPO	2016-02-05
Z-1184-2016	Class II	Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher	Stryker Medical	INK	2016-02-05
Z-1265-2016	Class II	Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total...	Zimmer GmbH	MBH	2016-02-05
Z-1042-2016	Class II	Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile...	Volcano Corporation	KKX	2016-02-05
Z-1041-2016	Class II	Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment...	Volcano Corporation	KKX	2016-02-05
Z-1079-2016	Class II	Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog...	Siemens Healthcare Diagnostics Inc.	JIX	2016-02-04
Z-1078-2016	Class II	Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number...	Siemens Healthcare Diagnostics Inc.	JIX	2016-02-04
Z-1077-2016	Class II	Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number...	Siemens Healthcare Diagnostics Inc.	JIX	2016-02-04
Z-1023-2016	Class III	Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems...	Medtronic Perfusion Systems	DWF	2016-02-04
Z-1396-2016	Class II	Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable...	Bard Peripheral Vascular Inc	FCG	2016-02-04
Z-0911-2016	Class I	MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the...	Abbott Vascular	NKM	2016-02-04
Z-0827-2016	Class I	Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.	Draeger, Inc.	CBK	2016-02-04
Z-1040-2016	Class II	50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting...	Stryker Corp.	GDF	2016-02-04
Z-1039-2016	Class II	50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting...	Stryker Corp.	GDF	2016-02-04
Z-1038-2016	Class II	(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at...	Stryker Corp.	GDF	2016-02-04
Z-1037-2016	Class II	(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle...	Stryker Corp.	GDF	2016-02-04
Z-1019-2016	Class II	Virage OCT Spinal Fixation System. Intended to promote fusion of the...	Zimmer Spine, Inc.	KWP	2016-02-03
Z-1036-2016	Class II	PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical...	Medical Action Industries, Inc. 306	FRO	2016-02-03
Z-1230-2016	Class II	QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test...	Qiagen	NCD	2016-02-02
Z-2353-2016	Class II	S3 MedSurg Bed, Model 3005. Stryker Medical	Stryker Medical	FNL	2016-02-02
Z-1177-2016	Class III	Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as...	Volk Optical Inc	HJK	2016-02-02
Z-0886-2016	Class II	Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only...	Teleflex Medical	FZP	2016-02-02
Z-1270-2016	Class II	Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in...	Ellex Medical Pty Ltd	HQF	2016-02-01
Z-2627-2016	Class II	RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2016-01-31
Z-2159-2016	Class II	Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.	Merge Healthcare Incorporated	LLZ	2016-01-31
Z-0664-2017	Class II	Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware...	Merge Healthcare Incorporated	OUG	2016-01-30
Z-0137-2017	Class II	CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2865-2016	Class II	Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2686-2016	Class II	iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland...	Merge Healthcare Incorporated	LMB	2016-01-30
Z-2685-2016	Class II	RadSuite software. The firm name on the label is Merge Healthcare, Hartland...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2379-2016	Class II	Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2532-2016	Class II	iConnect Access used with Ortho PACS software provides medical specialists with access to...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2531-2016	Class II	iConnect Access used with Merge PACS software provides medical specialists with access to...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2303-2016	Class II	Merge PACS software. The firm name on the label is Merge Healthcare, Hartland...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2301-2016	Class II	Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-2144-2016	Class II	Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland...	Merge Healthcare Incorporated	LLZ	2016-01-30
Z-1699-2016	Class II	Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured...	Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)	N/A	2016-01-29
Z-1528-2016	Class II	Trinity Acetabular Shell Product Usage Total Hip Replacement.	Corin USA	LZO	2016-01-29
Z-1527-2016	Class II	Trinity Acetabular Shell Product Usage: Total Hip Replacement.	Corin USA	LZO	2016-01-29
Z-1526-2016	Class II	Trinity Acetabular System Product Usage - Total Hip Replacement.	Corin USA	LZO	2016-01-29
Z-1088-2016	Class II	Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging...	Medtronic Navigation, Inc	OWB	2016-01-29
Z-0826-2016	Class II	software for Syngo Dynamics a Picture Archiving and Communication System (PACS)...	Siemens Medical Solutions USA, Inc.	LLZ	2016-01-29
Z-1032-2016	Class II	PINPOINT Endoscopic Fluorescence Imaging System	Novadaq Technologies ULC	GCJ	2016-01-29
Z-1082-2016	Class II	Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates...	Zimmer GmbH	LXT	2016-01-29
Z-1035-2016	Class I	GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope...	Verathon Inc.	CCW	2016-01-29
Z-1070-2016	Class II	Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111	ConforMIS, Inc.	JWH	2016-01-28
Z-1047-2016	Class II	Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and...	Gi Supply	LRO	2016-01-28