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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 762 of 1190

FDA device recalls, page 762 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0949-2013	Class II	TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used...	Hill-Rom Inc.	IOQ	2013-02-26
Z-1012-2013	Class III	Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1011-2013	Class III	Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1010-2013	Class III	Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1009-2013	Class III	Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1008-2013	Class III	Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1007-2013	Class III	Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1006-2013	Class III	Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1005-2013	Class III	Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1004-2013	Class III	Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number...	CooperSurgical, Inc.	HHW	2013-02-26
Z-1053-2013	Class II	LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin...	CooperSurgical, Inc.	MQB	2013-02-26
Z-1018-2013	Class II	Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model...	CooperSurgical, Inc.	HDW	2013-02-26
Z-0974-2013	Class II	INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual...	Intio Inc	LLZ	2013-02-26
Z-2474-2015	Class II	CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for...	Baxter Healthcare Corporation	KDJ	2013-02-25
Z-2473-2015	Class II	MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with...	Baxter Healthcare Corporation	KDJ	2013-02-25
Z-2472-2015	Class II	MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482...	Baxter Healthcare Corporation	KDJ	2013-02-25
Z-2471-2015	Class II	MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code...	Baxter Healthcare Corporation	KDJ	2013-02-25
Z-1154-2013	Class II	Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)	Nova Biomedical Corporation	CGA	2013-02-25
Z-1153-2013	Class II	Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214	Nova Biomedical Corporation	CGA	2013-02-25
Z-1140-2013	Class II	Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack...	Trividia Health, Inc.	NBW	2013-02-25
Z-1130-2013	Class II	LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing...	Lifescan, Inc.	JJX	2013-02-25
Z-1129-2013	Class II	LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808...	Lifescan, Inc.	JJX	2013-02-25
Z-0940-2013	Class I	GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual...	Symbios Medical Products, LLC	MEB	2013-02-25
Z-0972-2013	Class II	ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision...	Depuy Orthopaedics Inc.	HTO	2013-02-25
Z-1436-2014	Class II	Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro...	Clinical Diagnostic Solutions, Inc.	JPK	2013-02-24
Z-1061-2013	Class II	Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica...	Howmedica Osteonics Corp	JWH	2013-02-23
Z-1549-2013	Class II	Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated...	Leica Biosystems Imaging, Inc.	IBM	2013-02-22
Z-1557-2013	Class II	Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011	Synthes GmbH	HRS	2013-02-22
Z-1238-2013	Class II	Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial...	Synthes GmbH	KWI	2013-02-22
Z-1076-2013	Class II	Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC...	Sybron Dental Specialties, Inc.	MZW	2013-02-22
Z-1049-2013	Class II	Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus...	Siemens Healthcare Diagnostics Inc.	CEO	2013-02-22
Z-1151-2013	Class II	Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in...	Siemens Healthcare Diagnostics Inc.	KXT	2013-02-21
Z-1138-2013	Class II	OsteoSelect DBM Putty Product Usage: Orthopedic bone filler	Xtant Medical Holdings, Inc.	MBP	2013-02-21
Z-0910-2013	Class II	Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with...	Bard Access Systems, Inc.	DYB	2013-02-21
Z-0909-2013	Class II	Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart...	Bard Access Systems, Inc.	DYB	2013-02-21
Z-1418-2013	Class II	Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety...	Spinal Solutions, LLC	KWQ	2013-02-20
Z-1417-2013	Class II	Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead...	Spinal Solutions, LLC	MAX	2013-02-20
Z-1416-2013	Class II	14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1415-2013	Class II	12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1414-2013	Class II	60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1413-2013	Class II	50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1412-2013	Class II	40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1411-2013	Class II	Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1410-2013	Class II	50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of...	Spinal Solutions, LLC	MNI	2013-02-20
Z-1386-2013	Class II	Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball...	Orthopedic Alliance, LLC	LZO	2013-02-20
Z-1385-2013	Class II	Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz...	Orthopedic Alliance, LLC	LZO	2013-02-20
Z-1384-2013	Class II	Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone...	Orthopedic Alliance, LLC	HWC	2013-02-20
Z-1383-2013	Class II	Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm...	Orthopedic Alliance, LLC	KWY	2013-02-20
Z-1382-2013	Class II	Femoral head, standard, 26mm, +0mm Femoral head,medium, 26mm,+3mm Femoral head, long...	Orthopedic Alliance, LLC	LPH	2013-02-20
Z-1381-2013	Class II	U2 Acetabular cup, Ti beads porous coated, 44mm U2 Acetabular cup, Ti beads porous...	Orthopedic Alliance, LLC	LPH	2013-02-20