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 783 of 1190

FDA device recalls, page 783 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2411-2012	Class II	Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to...	Haag-Streit USA Inc	HPT	2012-08-17
Z-1216-2013	Class II	KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD...	Karl Storz Endoscopy-America, Inc.	OAY	2012-08-16
Z-2401-2012	Class II	Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by...	ZOLL Medical Corporation	MKJ	2012-08-16
Z-2376-2012	Class II	GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging...	GE Healthcare	MQB	2012-08-16
Z-1186-2016	Class II	Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz...	LivaNova USA, Inc.	DWC	2012-08-15
Z-2394-2012	Class III	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use...	Aquabiliti	NGT	2012-08-15
Z-2393-2012	Class III	0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use...	Aquabiliti	NGT	2012-08-15
Z-0204-2013	Class II	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel Up*Surgical Specialties Corporation...	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	GES	2012-08-15
Z-0203-2013	Class II	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel Up*Surgical Specialties Corporation...	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	GES	2012-08-15
Z-0202-2013	Class II	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel Up*Surgical Specialties Corporation...	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	GES	2012-08-15
Z-0201-2013	Class II	"*Sharpoint IQ Geometry Slit Knife Angled, Bevel Up*Surgical Specialties Corporation...	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	GES	2012-08-15
Z-2303-2012	Class II	Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275...	Philips North America LLC	DXN	2012-08-15
Z-0784-2013	Class II	THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera...	Lansinoh Laboratories Inc	IME	2012-08-14
Z-2383-2012	Class II	Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14...	Varian Medical Systems, Inc.	IYE	2012-08-14
Z-2384-2012	Class II	Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic...	Philips North America LLC	MQB	2012-08-14
Z-2399-2012	Class II	JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be...	Zimmer GmbH	LRY	2012-08-14
Z-1944-2013	Class II	GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified...	GE Healthcare	IYN	2012-08-13
Z-0291-2013	Class I	Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800...	Datascope Corp.	BSZ	2012-08-13
Z-0290-2013	Class I	Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800...	Datascope Corp.	BSZ	2012-08-13
Z-2454-2012	Class II	Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The...	Neomend Inc	NBE	2012-08-13
Z-0186-2013	Class II	Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea...	Canon Medical Informatics, Inc.	LLZ	2012-08-13
Z-1217-2013	Class II	MyRay RXDC dental unit x-ray unit	Cefla S.C.	EHD	2012-08-10
Z-0045-2013	Class II	IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box...	Immunodiagnostic Systems Ltd.	JIT	2012-08-10
Z-0044-2013	Class II	IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing...	Immunodiagnostic Systems Ltd.	CIN	2012-08-10
Z-0043-2013	Class II	IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing...	Immunodiagnostic Systems Ltd.	NEO	2012-08-10
Z-0042-2013	Class II	IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing...	Immunodiagnostic Systems Ltd.	NEO	2012-08-10
Z-0041-2013	Class II	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830...	Immunodiagnostic Systems Ltd.	CIN	2012-08-10
Z-0040-2013	Class II	IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in...	Immunodiagnostic Systems Ltd.	CIN	2012-08-10
Z-0039-2013	Class II	IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box...	Immunodiagnostic Systems Ltd.	JMM	2012-08-10
Z-2377-2012	Class II	Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog...	Philips North America LLC	MWI	2012-08-10
Z-2284-2012	Class II	QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization...	STERIS Corporation	MED	2012-08-10
Z-0382-2013	Class II	SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL...	Howmedica Osteonics Corp	LXH	2012-08-09
Z-0381-2013	Class II	Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I...	Howmedica Osteonics Corp	LXH	2012-08-09
Z-0380-2013	Class II	Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I...	Howmedica Osteonics Corp	LXH	2012-08-09
Z-2448-2012	Class II	Irrigation Catheters (Models IRR-XXX-XX): Model Numbers &...	Applied Medical Resources Corp	DQY	2012-08-09
Z-2447-2012	Class II	Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752...	Applied Medical Resources Corp	FGE	2012-08-09
Z-2446-2012	Class II	Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers &...	Applied Medical Resources Corp	DXE	2012-08-09
Z-2429-2012	Class II	Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is...	Integra LifeSciences Corporation	HAW	2012-08-09
Z-2428-2012	Class II	Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly...	Integra LifeSciences Corporation	HAW	2012-08-09
Z-2375-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2374-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2373-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2372-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2371-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2370-2012	Class II	Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The...	Omni Life Science, Inc.	JWH	2012-08-09
Z-2321-2012	Class II	AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404...	AmeriWater LLC.	FIP	2012-08-09
Z-0408-2013	Class II	Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge...	Siemens Healthcare Diagnostics Inc.	KLS	2012-08-09
Z-2339-2012	Class II	Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS...	Intuitive Surgical, Inc.	NAY	2012-08-09
Z-2302-2012	Class II	3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE...	Encore Medical, LP	OIY	2012-08-09
Z-2252-2012	Class II	AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with...	AGFA Healthcare Corp.	LLZ	2012-08-09