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 780 of 1190

FDA device recalls, page 780 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0207-2013	Class II	Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails)...	Orthopediatrics Corp	HSB	2012-09-13
Z-0022-2013	Class II	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas...	3M Company	FLF	2012-09-13
Z-0062-2013	Class II	CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are...	Zimmer GmbH	JDI	2012-09-13
Z-0124-2013	Class I	HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917...	HeartSine Technologies Ltd	MKJ	2012-09-13
Z-0061-2013	Class II	CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary...	Zimmer GmbH		2012-09-13
Z-0060-2013	Class II	CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented...	Zimmer GmbH		2012-09-13
Z-0385-2013	Class II	The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist...	Mako Surgical Corp.	OLO	2012-09-12
Z-2464-2012	Class II	Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance...	Siemens Medical Solutions USA, Inc.	LNH	2012-09-12
Z-2494-2012	Class II	Philips Digital Diagnost with patient carriage Model: 712050 with serial number range...	Philips North America LLC	MQB	2012-09-12
Z-0675-2013	Class II	Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips...	Philips North America LLC	JAK	2012-09-11
Z-0162-2013	Class II	Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50...	Siemens Healthcare Diagnostics Inc.	MOI	2012-09-11
Z-0011-2013	Class II	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The...	Philips North America LLC	MKJ	2012-09-11
Z-2573-2014	Class II	Streamline CT Cervico-Thoracic System; Set Screw Ref 26-Setscrew Non-Sterile, Single Use...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	2012-09-10
Z-0785-2013	Class II	Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person...	Invacare GmbH	IOR	2012-09-10
Z-2443-2012	Class II	Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-09-10
Z-1125-2013	Class II	Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR...	Instrumentation Industries, Incorporated	BTL	2012-09-07
Z-0396-2014	Class II	Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number...	Synthes GmbH	NKB	2012-09-07
Z-0395-2014	Class II	Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part...	Synthes GmbH	NKB	2012-09-07
Z-0024-2013	Class II	Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue...	Optovue Inc.	OBO	2012-09-07
Z-0010-2013	Class II	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is...	C.R. Bard Inc	KOD	2012-09-07
Z-2493-2012	Class II	Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the...	Zimmer GmbH	JWH	2012-09-07
Z-0015-2013	Class I	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette...	Baxter Healthcare Corporation	FPA	2012-09-07
Z-0014-2013	Class I	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette...	Baxter Healthcare Corporation	FPA	2012-09-07
Z-0013-2013	Class I	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette...	Baxter Healthcare Corporation	FPA	2012-09-07
Z-0012-2013	Class I	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip...	Baxter Healthcare Corporation	FPA	2012-09-07
Z-0008-2013	Class III	Sterile, single-use, disposable electrosurgical electrode holder. It connects the...	Gynex Corporation	HGI	2012-09-06
Z-2459-2012	Class II	Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by...	Greatbatch Medical	DRA	2012-09-06
Z-2465-2012	Class II	Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector...	Philips North America LLC	MQB	2012-09-06
Z-0155-2013	Class II	SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0154-2013	Class II	SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0153-2013	Class II	SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0152-2013	Class II	SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0151-2013	Class II	SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0150-2013	Class II	SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0149-2013	Class II	SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0148-2013	Class II	SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0147-2013	Class II	Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0146-2013	Class II	SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0145-2013	Class II	SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0144-2013	Class II	SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0143-2013	Class II	SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0142-2013	Class II	SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0141-2013	Class II	SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0140-2013	Class II	SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are...	DePuy Mitek, Inc.	HWC	2012-09-06
Z-0742-2013	Class II	Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare...	Datascope Corp.	MWI	2012-09-05
Z-0783-2013	Class II	Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A...	The Anspach Effort, Inc.	HTT	2012-09-05
Z-0296-2013	Class II	ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by...	Zimmer GmbH	KCY	2012-09-05
Z-0185-2013	Class II	Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000...	Wright Medical Technology Inc	LPH	2012-09-05
Z-0184-2013	Class II	Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT...	Wright Medical Technology Inc	LPH	2012-09-05
Z-0183-2013	Class II	Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080...	Wright Medical Technology Inc	LPH	2012-09-05