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 569 of 1191

FDA device recalls, page 569 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0122-2017	Class II	25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a...	Synergetics Inc	HQE	2016-08-11
Z-0121-2017	Class II	25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part...	Synergetics Inc	HQE	2016-08-11
Z-0120-2017	Class II	25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number...	Synergetics Inc	HQE	2016-08-11
Z-0119-2017	Class II	25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E...	Synergetics Inc	HQE	2016-08-11
Z-2803-2016	Class II	RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366...	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2802-2016	Class II	RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2801-2016	Class II	RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179...	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2800-2016	Class II	Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2799-2016	Class II	Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730...	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2798-2016	Class II	Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093...	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-2797-2016	Class II	Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number...	Siemens Healthcare Diagnostics Inc.	CHL	2016-08-11
Z-0352-2017	Class II	Rigid Suction Canister 3000 CC and 2000 CC.	MEDLINE INDUSTRIES, LP - Northfield	KDQ	2016-08-10
Z-2828-2016	Class II	Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and...	Abbott Medical	DRS	2016-08-10
Z-2827-2016	Class II	Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze...	Abbott Medical	DRS	2016-08-10
Z-2826-2016	Class II	Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless...	Abbott Medical	DRS	2016-08-10
Z-2825-2016	Class II	TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item...	Abbott Medical	DRS	2016-08-10
Z-2824-2016	Class II	Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze...	Abbott Medical	DRS	2016-08-10
Z-2823-2016	Class II	Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22...	Abbott Medical	DRS	2016-08-10
Z-2822-2016	Class II	5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable...	Abbott Medical	DRS	2016-08-10
Z-2821-2016	Class II	Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac...	Abbott Medical	DRS	2016-08-10
Z-2820-2016	Class II	Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The...	Abbott Medical	DRS	2016-08-10
Z-2819-2016	Class II	SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac...	Abbott Medical	DRS	2016-08-10
Z-2818-2016	Class II	Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac...	Abbott Medical	DRS	2016-08-10
Z-2817-2016	Class II	Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The...	Abbott Medical	DRS	2016-08-10
Z-2816-2016	Class II	Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The...	Abbott Medical	DRS	2016-08-10
Z-2815-2016	Class II	Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac...	Abbott Medical	DRS	2016-08-10
Z-2814-2016	Class II	Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The...	Abbott Medical	DRS	2016-08-10
Z-2813-2016	Class II	Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush...	Abbott Medical	DRS	2016-08-10
Z-2812-2016	Class II	Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports...	Abbott Medical	DRS	2016-08-10
Z-2811-2016	Class II	Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing...	Abbott Medical	DRS	2016-08-10
Z-2810-2016	Class II	Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL...	Abbott Medical	DRS	2016-08-10
Z-2809-2016	Class II	Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84"...	Abbott Medical	DRS	2016-08-10
Z-2808-2016	Class II	Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable...	Abbott Medical	DRS	2016-08-10
Z-2807-2016	Class II	Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless...	Abbott Medical	DRS	2016-08-10
Z-2806-2016	Class II	Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch...	Abbott Medical	DRS	2016-08-10
Z-2805-2016	Class II	Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir...	Abbott Medical	DRS	2016-08-10
Z-2764-2016	Class II	Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated...	Blackrock Microsystems	GWL	2016-08-10
Z-2763-2016	Class II	Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The...	Blackrock Microsystems	GWL	2016-08-10
Z-3248-2018	Class II	ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging	SWISSRAY Medical, AG	KPR	2016-08-09
Z-0111-2017	Class II	Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee...	Zimmer GmbH	JWH	2016-08-09
Z-0084-2017	Class II	Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic...	Zimmer GmbH	LXH	2016-08-09
Z-0083-2017	Class II	Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and...	Zimmer GmbH	FZX	2016-08-09
Z-0326-2017	Class II	Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail...	Hill-Rom Inc.	FSA	2016-08-09
Z-2854-2016	Class II	EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter	EKOS Corporation	KRA	2016-08-09
Z-2870-2016	Class II	MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12"...	Global Healthcare, Inc.	FMI	2016-08-09
Z-2742-2016	Class II	ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293...	Siemens Healthcare Diagnostics Inc.	LTJ	2016-08-09
Z-2781-2016	Class II	CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for...	Mentor	LCJ	2016-08-09
Z-2780-2016	Class II	Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for...	Mentor	LCJ	2016-08-09
Z-2748-2016	Class II	MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with...	Mentor	LCJ	2016-08-09
Z-2747-2016	Class II	MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with...	Mentor	LCJ	2016-08-09