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 786 of 1190

FDA device recalls, page 786 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2135-2012	Class II	RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable (...	Stryker Corp.	GXI	2012-07-17
Z-2134-2012	Class II	RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable (...	Stryker Corp.	GXI	2012-07-17
Z-0493-2013	Class II	DataCare POC is an information management system that provides data management...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0492-2013	Class II	DataCara GM is an information management system that provides data management...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0491-2013	Class II	DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0490-2013	Class II	The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0489-2013	Class II	The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0488-2013	Class II	LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0487-2013	Class II	LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0486-2013	Class II	The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0485-2013	Class II	The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0484-2013	Class II	Data Station AMPLILINK software is an instrument user interface/ data management software...	Roche Molecular Systems Inc	NSX	2012-07-16
Z-0286-2013	Class II	Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension...	Howmedica Osteonics Corp	JDI	2012-07-16
Z-2146-2012	Class II	djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of...	Encore Medical, LP	HWC	2012-07-16
Z-0005-2013	Class II	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose...	Animas Corp.	LZG	2012-07-16
Z-2368-2012	Class II	Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body...	Lucero Medical, LLC	MQP	2012-07-15
Z-2145-2012	Class II	Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number...	Smith & Nephew, Inc.	GEI	2012-07-14
Z-2144-2012	Class II	Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part...	Smith & Nephew, Inc.	GEI	2012-07-14
Z-2122-2012	Class II	The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer...	STERIS Corporation	MEC	2012-07-14
Z-1833-2013	Class II	GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device...	GE Healthcare	IYN	2012-07-13
Z-2075-2012	Class II	Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2...	Abbott Medical	FPA	2012-07-13
Z-2219-2012	Class II	syngo Dynamics Version 9.5	Siemens Medical Solutions USA, Inc.	LLZ	2012-07-13
Z-2142-2012	Class I	AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated...	Baxter Healthcare Corporation	NEP	2012-07-13
Z-2141-2012	Class I	AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated...	Baxter Healthcare Corporation	NEP	2012-07-13
Z-2140-2012	Class I	AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition...	Baxter Healthcare Corporation	NEP	2012-07-13
Z-2139-2012	Class I	AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders...	Baxter Healthcare Corporation	NEP	2012-07-13
Z-2106-2012	Class II	ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2105-2012	Class II	KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2104-2012	Class II	KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2103-2012	Class II	KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2102-2012	Class II	KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2101-2012	Class II	INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the...	Intuitive Surgical, Inc.	NAY	2012-07-13
Z-2058-2012	Class II	Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz...	Westone Laboratories, Inc.	KMJ	2012-07-13
Z-2187-2012	Class II	The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026...	Zimmer GmbH	HRS	2012-07-13
Z-2256-2013	Class II	GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter...	GE Healthcare	MHX	2012-07-12
Z-2460-2012	Class II	Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a...	Alere San Diego, Inc.	LDP	2012-07-12
Z-2114-2012	Class II	Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant...	Aesculap Inc	HWT	2012-07-12
Z-1584-2015	Class II	ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number...	Siemens Medical Solutions USA, Inc.	IYN	2012-07-11
Z-0181-2013	Class I	AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab...	Salter Labs	BTM	2012-07-11
Z-0180-2013	Class I	AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab...	Salter Labs	BTM	2012-07-11
Z-0179-2013	Class I	Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce...	Salter Labs	BTM	2012-07-11
Z-0178-2013	Class I	Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce...	Salter Labs	BTM	2012-07-11
Z-0177-2013	Class I	Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce...	Salter Labs	BTM	2012-07-11
Z-0176-2013	Class I	Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable...	Salter Labs	BTM	2012-07-11
Z-0175-2013	Class I	AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by...	Salter Labs	BTM	2012-07-11
Z-0174-2013	Class I	Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by...	Salter Labs	BTM	2012-07-11
Z-0173-2013	Class I	V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by...	Salter Labs	BTM	2012-07-11
Z-0172-2013	Class I	Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2...	Salter Labs	BTM	2012-07-11
Z-0171-2013	Class I	Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators...	Salter Labs	BTM	2012-07-11
Z-0170-2013	Class I	Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by...	Salter Labs	BTM	2012-07-11