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 752 of 1191

FDA device recalls, page 752 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1501-2013	Class II	Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1500-2013	Class II	Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1499-2013	Class II	Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use...	Stryker Corp.	FYA	2013-05-23
Z-1498-2013	Class II	Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use...	Stryker Corp.	FYA	2013-05-23
Z-1497-2013	Class II	Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single...	Stryker Corp.	FYA	2013-05-23
Z-1496-2013	Class II	Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product...	Stryker Corp.	FYA	2013-05-23
Z-1495-2013	Class II	Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product...	Stryker Corp.	FYA	2013-05-23
Z-1494-2013	Class II	Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1670-2013	Class II	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system...	Advanced Medical Optics, Inc.	HQC	2013-05-23
Z-1493-2013	Class II	Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1492-2013	Class II	Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1491-2013	Class II	Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single...	Stryker Corp.	FYA	2013-05-23
Z-1490-2013	Class II	Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1489-2013	Class II	Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use...	Stryker Corp.	FYA	2013-05-23
Z-1620-2013	Class II	Bigliani/Flatow The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40...	Zimmer GmbH	LXH	2013-05-23
Z-1555-2013	Class II	BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling...	Handicare USA, Inc.	FSA	2013-05-23
Z-1554-2013	Class II	BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling...	Handicare USA, Inc.	FSA	2013-05-23
Z-1553-2013	Class II	BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling...	Handicare USA, Inc.	FSA	2013-05-23
Z-1552-2013	Class II	BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The...	Handicare USA, Inc.	FSA	2013-05-23
Z-2277-2013	Class II	Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment...	Elekta Limited	MUJ	2013-05-22
Z-1846-2013	Class II	GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics...	Howmedica Osteonics Corp	HSB	2013-05-21
Z-1565-2013	Class II	Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation...	Baxter Healthcare Corporation	KDI	2013-05-21
Z-1786-2013	Class II	STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is...	STERIS Corporation	HST	2013-05-20
Z-0430-2014	Class II	Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to...	Siemens Healthcare Diagnostics Inc.	JJE	2013-05-20
Z-0329-2014	Class II	Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove...	OLYMPUS Corporation of the Americas	FEQ	2013-05-20
Z-1664-2013	Class II	BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and...	SPINEFRONTIER, Inc. dba LESspine Innovations	FSM	2013-05-17
Z-1597-2013	Class II	Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies...	RF Technologies, Inc.	KMI	2013-05-17
Z-1587-2013	Class II	Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated...	U-Systems, Inc.	PAA	2013-05-16
Z-1584-2013	Class II	CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional...	Roche Diagnostics GmbH	GJS	2013-05-16
Z-1583-2013	Class II	CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare...	Roche Diagnostics GmbH	GJS	2013-05-16
Z-1582-2013	Class II	CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and...	Roche Diagnostics GmbH	GJS	2013-05-16
Z-1581-2013	Class II	CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS...	Roche Diagnostics GmbH	GJS	2013-05-16
Z-0864-2014	Class II	Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized...	Cerenovus, Inc.	JXG	2013-05-16
Z-0863-2014	Class II	Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and...	Cerenovus, Inc.	JXG	2013-05-16
Z-0862-2014	Class II	Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and...	Cerenovus, Inc.	JXG	2013-05-16
Z-0861-2014	Class II	Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code...	Cerenovus, Inc.	JXG	2013-05-16
Z-0860-2014	Class II	Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and...	Cerenovus, Inc.	JXG	2013-05-16
Z-0859-2014	Class II	Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product...	Cerenovus, Inc.	JXG	2013-05-16
Z-0858-2014	Class II	Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product...	Cerenovus, Inc.	JXG	2013-05-16
Z-0443-2014	Class II	Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software...	Gentherm Medical, LLC	DWJ	2013-05-15
Z-0100-2014	Class II	pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs...	Sysmex America, Inc.	GKZ	2013-05-15
Z-1830-2013	Class II	AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II...	Tosoh Bioscience Inc	KHO	2013-05-15
Z-1684-2013	Class II	Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers...	Baxter Healthcare Corporation	LJH	2013-05-15
Z-1683-2013	Class II	Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers...	Baxter Healthcare Corporation	LJH	2013-05-15
Z-1487-2013	Class II	AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in...	AGFA Healthcare Corp.	IZL	2013-05-15
Z-1548-2013	Class II	Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision...	Zimmer GmbH	PAO	2013-05-15
Z-1682-2013	Class II	Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code...	Baxter Healthcare Corporation	LJH	2013-05-15
Z-1451-2013	Class II	Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G...	Maytex Corp	FXX	2013-05-15
Z-2187-2013	Class II	StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device...	Spine Wave Inc	MAX	2013-05-14
Z-1572-2013	Class II	MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions...	Maquet Cardiovascular Us Sales, LLC	FGY	2013-05-14