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 302 of 1190

FDA device recalls, page 302 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1188-2021	Class II	Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid...	Siemens Healthcare Diagnostics Inc.	JHM	2021-02-03
Z-1200-2021	Class II	Thread-like wire marker	SOMATEX Medical Technologies GmbH	MIJ	2021-02-03
Z-1306-2021	Class I	Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy...	Medtronic, Inc.	NIK	2021-02-03
Z-1305-2021	Class I	Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR...	Medtronic, Inc.	LWS	2021-02-03
Z-1671-2021	Class II	IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version...	Philips North America LLC	DSI	2021-02-02
Z-1328-2021	Class II	Alcon Custom Ophthalmic Surgical Procedure Packs	Alcon Laboratories	LRO	2021-02-02
Z-1276-2021	Class II	Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #...	Epimed International, Inc.	BSO	2021-02-01
Z-1202-2021	Class II	Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910	Thermo Fisher Scientific Oy	DOP	2021-02-01
Z-1203-2021	Class II	Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT...	Insulet Corporation	LZG	2021-02-01
Z-1155-2021	Class II	ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting...	Apyx Medical Corporation	GEI	2021-02-01
Z-1154-2021	Class II	HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting...	Apyx Medical Corporation	GEI	2021-02-01
Z-1153-2021	Class II	Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting...	Apyx Medical Corporation	GEI	2021-02-01
Z-1297-2021	Class II	S-Series Equipment Management System; Model Number(s):0682400550; UDI...	STRYKER Communications, Inc.	FQO	2021-01-29
Z-1181-2021	Class II	Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia...	Getinge Group Logistics America, LLC	BSZ	2021-01-29
Z-1180-2021	Class II	ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327...	Draeger, Inc.	OFP	2021-01-29
Z-1179-2021	Class II	VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number...	Draeger, Inc.	OFP	2021-01-29
Z-1178-2021	Class II	VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353...	Draeger, Inc.	OFP	2021-01-29
Z-1177-2021	Class II	VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number...	Draeger, Inc.	OFP	2021-01-29
Z-1126-2021	Class II	Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF...	Confirm Biosciences LLC	QKO	2021-01-29
Z-1125-2021	Class II	Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a...	Confirm Biosciences LLC	QKO	2021-01-29
Z-1280-2021	Class II	Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203)...	Baxter Healthcare Corporation	KDI	2021-01-28
Z-1308-2021	Class II	VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the...	bioMerieux, Inc.	LON	2021-01-28
Z-1279-2021	Class II	Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy...	Baxter Healthcare Corporation	KDI	2021-01-28
Z-1278-2021	Class II	Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy...	Baxter Healthcare Corporation	KDI	2021-01-28
Z-1409-2021	Class III	Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of...	OriGen Biomedical, Inc.	KJA	2021-01-28
Z-1277-2021	Class II	Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy...	Baxter Healthcare Corporation	KDI	2021-01-28
Z-1292-2021	Class II	Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video...	OLYMPUS Corporation of the Americas	FDT	2021-01-28
Z-1307-2021	Class II	VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external...	bioMerieux, Inc.	LON	2021-01-28
Z-1163-2021	Class II	TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage...	Advanced Medical Optics, Inc.	MJP	2021-01-27
Z-1173-2021	Class II	Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C...	Siemens Medical Solutions USA, Inc.	DQK	2021-01-27
Z-1158-2021	Class II	BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product...	BioFire Diagnostics, LLC	PEN	2021-01-26
Z-1157-2021	Class II	Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture...	BioFire Diagnostics, LLC	PEN	2021-01-26
Z-1291-2021	Class II	Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System...	Corin Limited	MEH	2021-01-25
Z-1290-2021	Class II	Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular...	Corin Limited	MEH	2021-01-25
Z-1160-2021	Class II	Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01)...	Shanghai United Imaging Healthcare Co., Ltd.	KPR	2021-01-25
Z-1249-2021	Class II	RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the...	MEDLINE INDUSTRIES, LP - Northfield	JPK	2021-01-25
Z-1140-2021	Class II	Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11...	DeRoyal Industries, Inc.	LRO	2021-01-25
Z-1139-2021	Class II	Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10...	DeRoyal Industries, Inc.	LRO	2021-01-25
Z-1138-2021	Class II	CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d)...	DeRoyal Industries, Inc.	LRO	2021-01-25
Z-2039-2023	Class II	Radiation therapy software, RayStation standalone software treatment planning system...	RaySearch Americas Inc.	MUJ	2021-01-22
Z-1172-2021	Class II	Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY	Barco N.V.	PGY	2021-01-22
Z-1161-2021	Class I	ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound...	Acist Medical Systems, Inc.	OBJ	2021-01-22
Z-1164-2021	Class II	Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as...	G & H Wire Company	ECI	2021-01-21
Z-1149-2021	Class II	OT1000 Series Orthopedic Surgical Tables	STERIS Corporation	JEA	2021-01-21
Z-1152-2021	Class II	Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem...	CooperSurgical, Inc.	HHW	2021-01-21
Z-1255-2021	Class II	Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological...	R & D Systems, Inc.	JNM	2021-01-20
Z-1347-2021	Class II	Enteral Infusion Pump	Medtronic, Inc.	LZH	2021-01-19
Z-1327-2021	Class II	Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7...	Stryker Sustainability Solutions	NLQ	2021-01-19
Z-1263-2021	Class II	Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an...	Merit Medical Systems, Inc.	DRC	2021-01-19
Z-1262-2021	Class II	HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an...	Merit Medical Systems, Inc.	DRC	2021-01-19