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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 693 of 1191

FDA device recalls, page 693 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2177-2014	Class II	Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is...	Eastman Kodak Company	KPR	2014-07-09
Z-2269-2014	Class II	Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical...	Gyrus ACMI, Inc.	KNH	2014-07-08
Z-0182-2015	Class II	Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code...	Philips North America LLC	OWB	2014-07-08
Z-0181-2015	Class II	Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version...	Philips North America LLC	OWB	2014-07-08
Z-2627-2014	Class II	Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the...	Howmedica Osteonics Corp	LXH	2014-07-07
Z-2626-2014	Class II	Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria...	Howmedica Osteonics Corp	LXH	2014-07-07
Z-2541-2014	Class I	H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit	Abbott Medical	BTR	2014-07-07
Z-2540-2014	Class I	H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit	Abbott Medical	BTR	2014-07-07
Z-2539-2014	Class I	H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric...	Abbott Medical	BTR	2014-07-07
Z-2538-2014	Class I	H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal...	Abbott Medical	BTR	2014-07-07
Z-2537-2014	Class I	H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric...	Abbott Medical	BTR	2014-07-07
Z-2141-2014	Class II	VITROS 5600 Integrated System --- For use in the in vitro quantitative...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-07-07
Z-2140-2014	Class II	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-07-07
Z-2139-2014	Class II	VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-07-07
Z-2292-2014	Class II	Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to...	Siemens Medical Solutions USA, Inc.	JAA	2014-07-07
Z-2067-2014	Class II	Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm...	Innovasis, Inc	NKB	2014-07-07
Z-2536-2014	Class I	4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal...	Abbott Medical	BTR	2014-07-07
Z-2114-2014	Class II	GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use...	GE Healthcare	MHX	2014-07-07
Z-2653-2014	Class II	VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear...	Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work	IYE	2014-07-05
Z-2138-2014	Class II	AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic...	Advandx, Inc.	NXX	2014-07-04
Z-2191-2014	Class II	Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and...	Cerenovus, Inc.	JXG	2014-07-03
Z-2190-2014	Class II	Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories...	Cerenovus, Inc.	JXG	2014-07-03
Z-2189-2014	Class II	Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product...	Cerenovus, Inc.	JXG	2014-07-03
Z-2188-2014	Class II	Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The...	Cerenovus, Inc.	JXG	2014-07-03
Z-2187-2014	Class II	Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product...	Cerenovus, Inc.	JXG	2014-07-03
Z-2186-2014	Class II	Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code...	Cerenovus, Inc.	JXG	2014-07-03
Z-2185-2014	Class II	Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The...	Cerenovus, Inc.	JXG	2014-07-03
Z-2184-2014	Class II	Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas...	Cerenovus, Inc.	JXG	2014-07-03
Z-2570-2014	Class II	CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/...	CooperSurgical, Inc.	LKF	2014-07-03
Z-2542-2014	Class II	BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog...	Becton Dickinson & Co	JCF	2014-07-03
Z-2267-2014	Class II	IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that...	Intelerad Medical Systems Incorporated	LLZ	2014-07-03
Z-1075-2015	Class I	The Plum A+ Infusion System is designed to meet the fluid delivery requirements of...	Abbott Medical	FRN	2014-07-02
Z-1074-2015	Class I	The Plum A+ Infusion System is designed to meet the fluid delivery requirements of...	Abbott Medical	FRN	2014-07-02
Z-1073-2015	Class I	The Plum A+ Infusion System is designed to meet the fluid delivery requirements of...	Abbott Medical	FRN	2014-07-02
Z-1072-2015	Class I	The Plum A+ Infusion System is designed to meet the fluid delivery requirements of...	Abbott Medical	FRN	2014-07-02
Z-1071-2015	Class I	The Plum A+ Infusion System is designed to meet the fluid delivery requirements of...	Abbott Medical	FRN	2014-07-02
Z-2586-2014	Class II	ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient...	GE Healthcare	MHX	2014-07-02
Z-2591-2014	Class II	EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline...	Mentor	MRD	2014-07-02
Z-2258-2014	Class II	TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith &...	Smith & Nephew, Inc.	JDS	2014-07-02
Z-2175-2014	Class II	DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing...	AGFA Healthcare Corp.	KPR	2014-07-02
Z-2117-2014	Class II	CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100...	Dynarex Corp.	CBP	2014-07-02
Z-2143-2014	Class III	Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels...	Eastman Kodak Company	IWZ	2014-07-02
Z-2142-2014	Class III	INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels...	Eastman Kodak Company	IWZ	2014-07-02
Z-2242-2014	Class II	Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL...	Zimmer GmbH	JWH	2014-07-01
Z-2289-2014	Class II	PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray...	Zimmer GmbH	FSM	2014-07-01
Z-2215-2014	Class II	Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm...	Zimmer GmbH	JDG	2014-07-01
Z-2288-2014	Class II	PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray...	Zimmer GmbH	FSM	2014-07-01
Z-2268-2014	Class II	Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0...	Ansar Group, Inc. dba Ansar Medical Technologies, Inc	DRT	2014-07-01
Z-2113-2014	Class II	InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.	Biogenex Laboratories, Inc.	MVC	2014-07-01
Z-2153-2014	Class II	Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for...	Revvity Health Sciences, Inc.	N/A	2014-07-01