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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 580 of 1191

FDA device recalls, page 580 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2199-2016	Class II	Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2198-2016	Class II	Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2197-2016	Class II	Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2196-2016	Class II	Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2195-2016	Class II	Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2194-2016	Class II	Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2193-2016	Class II	Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2192-2016	Class II	Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 &...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2191-2016	Class II	Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2190-2016	Class II	Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot #...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2189-2016	Class II	Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver...	Synthes (USA) Products LLC	HWE	2016-05-31
Z-2553-2016	Class II	METS SMILES Total Knee Replacement	Stanmore Implants Worldwide, Ltd.	KRO	2016-05-31
Z-2239-2016	Class II	ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to...	Hologic, Inc.	KDQ	2016-05-31
Z-0079-2017	Class II	Radiation Therapy Treatment Planning System, Model 5.0	RaySearch Laboratories AB (publ)	MUJ	2016-05-30
Z-0105-2018	Class II	ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders...	Zimmer GmbH	HAW	2016-05-27
Z-0037-2017	Class II	Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0036-2017	Class II	Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0035-2017	Class II	Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0034-2017	Class II	Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0033-2017	Class II	Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0032-2017	Class II	Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0031-2017	Class II	Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0030-2017	Class II	Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0029-2017	Class II	Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0028-2017	Class II	Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0027-2017	Class II	Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0026-2017	Class II	Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0025-2017	Class II	Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0024-2017	Class II	Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0023-2017	Class II	Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0022-2017	Class II	Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0021-2017	Class II	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0020-2017	Class II	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0019-2017	Class II	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0018-2017	Class II	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-0017-2017	Class II	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental...	Ivoclar Vivadent, Inc.	EIH	2016-05-27
Z-2125-2016	Class II	Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor...	Medtronic, Inc.	NVZ	2016-05-26
Z-2128-2016	Class II	Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems...	Exactech, Inc.	LZO	2016-05-26
Z-2127-2016	Class II	Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems...	Exactech, Inc.	LZO	2016-05-26
Z-2304-2016	Class II	ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin...	Roche Diagnostics GmbH	LEH	2016-05-26
Z-2256-2016	Class II	ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2...	Siemens Healthcare Diagnostics Inc.	JLW	2016-05-26
Z-2095-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-2094-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-2093-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-2092-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-2091-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-2090-2016	Class II	LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The...	Smith & Nephew, Inc.	KRO	2016-05-26
Z-0611-2017	Class II	iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.	Merge Healthcare Incorporated	LLZ	2016-05-25
Z-2737-2016	Class II	BrightView XCT Upgrade Model 882454	Philips North America LLC	KPS	2016-05-25
Z-2736-2016	Class II	BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography...	Philips North America LLC	KPS	2016-05-25