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 381 of 1190

FDA device recalls, page 381 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2553-2019	Class II	Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24"...	Natus Medical Denmark ApS	DSA	2019-08-01
Z-2484-2019	Class II	HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range...	Haag-Streit USA Inc	EPT	2019-07-31
Z-2483-2019	Class II	HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of...	Haag-Streit USA Inc	EPT	2019-07-31
Z-2482-2019	Class II	HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of...	Haag-Streit USA Inc	EPT	2019-07-31
Z-2405-2019	Class II	SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2404-2019	Class II	SOMATOM go.Top; Models #11061640 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2403-2019	Class II	SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2402-2019	Class II	SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2401-2019	Class II	SOMATOM go.Up; Models ##11061628 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2400-2019	Class II	SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-2399-2019	Class II	SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography...	Siemens Medical Solutions USA, Inc.	JAK	2019-07-31
Z-0193-2020	Class II	BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number...	Becton Dickinson & Co	FMI	2019-07-31
Z-0024-2020	Class II	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2...	Stryker Corp.	ETN	2019-07-31
Z-0023-2020	Class II	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2...	Stryker Corp.	ETN	2019-07-31
Z-1075-2022	Class II	Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h	Shanghai United Imaging Healthcare Co., Ltd.	KPR	2019-07-30
Z-2294-2020	Class II	RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use...	Eizo Corporation	PGY	2019-07-30
Z-2293-2020	Class II	RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is...	Eizo Corporation	PGY	2019-07-30
Z-2367-2019	Class II	Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient...	Siemens Medical Solutions USA, Inc.	OWB	2019-07-30
Z-0148-2020	Class II	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product...	Siemens Healthcare Diagnostics Inc.	JGS	2019-07-30
Z-2318-2019	Class I	Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF...	Teleflex Medical	BTR	2019-07-30
Z-2317-2019	Class I	Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management	Teleflex Medical	BTR	2019-07-30
Z-2316-2019	Class I	Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF...	Teleflex Medical	BTR	2019-07-30
Z-2315-2019	Class I	Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm...	Teleflex Medical	BTR	2019-07-30
Z-2314-2019	Class I	Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF...	Teleflex Medical	BTR	2019-07-30
Z-2313-2019	Class I	Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF...	Teleflex Medical	BTR	2019-07-30
Z-2312-2019	Class I	Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c)...	Teleflex Medical	BTR	2019-07-30
Z-2311-2019	Class I	Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF...	Teleflex Medical	BTR	2019-07-30
Z-2135-2020	Class II	Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait...	Motek Medical B.V.	BXB	2019-07-29
Z-1327-2020	Class II	OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565	The Binding Site Group Ltd.	CFN	2019-07-29
Z-0147-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	MRZ	2019-07-29
Z-0146-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	MRZ	2019-07-29
Z-0145-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	MRZ	2019-07-29
Z-0144-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0143-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0142-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0141-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0140-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0139-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	FRN	2019-07-29
Z-0138-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	FRN	2019-07-29
Z-0137-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	FRN	2019-07-29
Z-0136-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	FRN	2019-07-29
Z-0135-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0134-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0133-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0132-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0131-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0130-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	MRZ	2019-07-29
Z-0129-2020	Class II	Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with...	Abbott Medical	FRN	2019-07-29
Z-0128-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	FRN	2019-07-29
Z-0127-2020	Class II	Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline...	Abbott Medical	MRZ	2019-07-29