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 321 of 1190

FDA device recalls, page 321 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0316-2021	Class II	Flow Sensor Service Part, Catalog 2087640-001-S	GE Healthcare	BSZ	2020-09-17
Z-0315-2021	Class II	Flow Sensor Service Part, Catalog 2089610-001-S	GE Healthcare	BSZ	2020-09-17
Z-0092-2021	Class II	Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended...	Getinge Group Logistics America, LLC	CBK	2020-09-17
Z-0314-2021	Class II	9100c NXT system - Product Usage: Device is licensed and distributed outside of the US...	GE Healthcare	BSZ	2020-09-17
Z-0313-2021	Class II	GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide...	GE Healthcare	BSZ	2020-09-17
Z-0312-2021	Class II	GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general...	GE Healthcare	BSZ	2020-09-17
Z-0311-2021	Class II	Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System...	GE Healthcare	BSZ	2020-09-17
Z-0296-2021	Class II	LOM Disposable Surgical Gowns/Medical Gowns, Single-Use	Thread Counsel Inc dba Laws of Motion	FYA	2020-09-17
Z-0310-2021	Class II	A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended...	Genicon, Inc.	FZP	2020-09-17
Z-0124-2021	Class II	Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow...	Ortho-Clinical Diagnostics, Inc.	QKP	2020-09-17
Z-0456-2021	Class II	Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref...	Merit Medical Systems, Inc.	JSM	2020-09-16
Z-0455-2021	Class II	Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for...	Merit Medical Systems, Inc.	JSM	2020-09-16
Z-0454-2021	Class II	MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile...	Merit Medical Systems, Inc.	KXG	2020-09-16
Z-0286-2021	Class II	Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900...	Boston Scientific Corporation	FGE	2020-09-16
Z-0423-2021	Class II	3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by...	3M Company	DRX	2020-09-15
Z-0422-2021	Class II	3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by...	3M Company	DRX	2020-09-15
Z-0421-2021	Class II	3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by...	3M Company	DRX	2020-09-15
Z-0420-2021	Class II	Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to...	3M Company	DRX	2020-09-15
Z-0419-2021	Class II	Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to...	3M Company	DRX	2020-09-15
Z-0055-2021	Class II	Quick Release Gait Belt, 60	MEDLINE INDUSTRIES, LP - Northfield	IKX	2020-09-15
Z-0259-2024	Class II	Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.	Percussionaire Corp.	CBK	2020-09-14
Z-0068-2021	Class II	Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0067-2021	Class II	Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0066-2021	Class II	Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0065-2021	Class II	Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0064-2021	Class II	Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0063-2021	Class II	Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0062-2021	Class II	Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0061-2021	Class II	Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab...	MEDLINE INDUSTRIES, LP - Northfield	OEQ	2020-09-14
Z-0126-2021	Class III	MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance...	Invivo Corporation	MOS	2020-09-14
Z-0295-2021	Class II	Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral...	Becton Dickinson & Co	PND	2020-09-14
Z-0294-2021	Class II	Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral...	Becton Dickinson & Co	PND	2020-09-14
Z-0285-2021	Class II	Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers...	Philips North America LLC	MKJ	2020-09-14
Z-0284-2021	Class II	Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers...	Philips North America LLC	MKJ	2020-09-14
Z-0125-2021	Class II	BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No...	Becton Dickinson & Co	FOZ	2020-09-14
Z-0439-2021	Class II	Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343	Fresenius Medical Care Renal Therapies Group, LLC	FKX	2020-09-12
Z-0320-2021	Class II	Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MD...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	OLO	2020-09-11
Z-0878-2021	Class II	Synapse PACS Software Versions 5.1 and higher	FUJIFILM Healthcare Americas Corporation	LLZ	2020-09-11
Z-0282-2021	Class II	Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based...	FUJIFILM Healthcare Americas Corporation	LLZ	2020-09-11
Z-0071-2021	Class II	VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the...	Skytron, LLC	LMD	2020-09-11
Z-0180-2021	Class II	Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The...	Bien-Air Surgery SA	ERL	2020-09-11
Z-0179-2021	Class II	Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The...	Bien-Air Surgery SA	ERL	2020-09-11
Z-0178-2021	Class II	Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an...	Bien-Air Surgery SA	ERL	2020-09-11
Z-0177-2021	Class II	Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage...	Bien-Air Surgery SA	ERL	2020-09-11
Z-0176-2021	Class II	Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to...	Bien-Air Surgery SA	ERL	2020-09-11
Z-1258-2022	Class II	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with...	Tandem Diabetes Care, Inc.	PQF	2020-09-10
Z-0288-2021	Class II	Instructions For Use document of the GPS Trackers.	Blue Ortho	OLO	2020-09-10
Z-0806-2021	Class II	Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector...	Siemens Medical Solutions USA, Inc.	JAA	2020-09-09
Z-0805-2021	Class II	Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic...	Siemens Medical Solutions USA, Inc.	JAA	2020-09-09
Z-0175-2021	Class II	MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984	Smith & Nephew, Inc.	MAI	2020-09-09