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 430 of 1190

FDA device recalls, page 430 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0359-2020	Class II	TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor...	Trimed Inc	LXH	2018-09-28
Z-0358-2020	Class II	TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is...	Trimed Inc	LXH	2018-09-28
Z-0357-2020	Class II	TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm...	Trimed Inc	LXH	2018-09-28
Z-0356-2020	Class II	TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on...	Trimed Inc	LXH	2018-09-28
Z-0355-2020	Class II	TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label...	Trimed Inc	LXH	2018-09-28
Z-0409-2019	Class II	Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI...	Siemens Healthcare Diagnostics Inc.	JJE	2018-09-28
Z-0485-2019	Class II	Tosoh AIA-900 immunoassay Analyzer	Tosoh Bioscience Inc	KHO	2018-09-28
Z-0475-2019	Class II	AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is...	Tosoh Bioscience Inc	KHO	2018-09-28
Z-0600-2019	Class II	AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer...	Tosoh Bioscience Inc	KHO	2018-09-28
Z-0599-2019	Class II	AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer...	Tosoh Bioscience Inc	KHO	2018-09-28
Z-0178-2019	Class II	Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number...	Siemens Medical Solutions USA, Inc.	KPS	2018-09-28
Z-0177-2019	Class II	Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The...	Siemens Medical Solutions USA, Inc.	KPS	2018-09-28
Z-0403-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI...	Orthofix SRL	KTT	2018-09-27
Z-0402-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533	Orthofix SRL	KTT	2018-09-27
Z-0401-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI...	Orthofix SRL	KTT	2018-09-27
Z-0400-2020	Class II	ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922	Orthofix SRL	KTT	2018-09-27
Z-0399-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI...	Orthofix SRL	KTT	2018-09-27
Z-0398-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE...	Orthofix SRL	KTT	2018-09-27
Z-0397-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY...	Orthofix SRL	KTT	2018-09-27
Z-0396-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI...	Orthofix SRL	KTT	2018-09-27
Z-0395-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY...	Orthofix SRL	KTT	2018-09-27
Z-0394-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI...	Orthofix SRL	KTT	2018-09-27
Z-0393-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0392-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG...	Orthofix SRL	JDW	2018-09-27
Z-0391-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO...	Orthofix SRL	JDW	2018-09-27
Z-0390-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT...	Orthofix SRL	JDW	2018-09-27
Z-0389-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI...	Orthofix SRL	JDW	2018-09-27
Z-0388-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI...	Orthofix SRL	JDW	2018-09-27
Z-0387-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX...	Orthofix SRL	JDW	2018-09-27
Z-0386-2020	Class II	ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM...	Orthofix SRL	JDW	2018-09-27
Z-0385-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK...	Orthofix SRL	JDW	2018-09-27
Z-0384-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK...	Orthofix SRL	JDW	2018-09-27
Z-0383-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK...	Orthofix SRL	JDW	2018-09-27
Z-0382-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED...	Orthofix SRL	JDW	2018-09-27
Z-0381-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED...	Orthofix SRL	JDW	2018-09-27
Z-0380-2020	Class II	ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED...	Orthofix SRL	JDW	2018-09-27
Z-0379-2020	Class II	ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0378-2020	Class II	ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0377-2020	Class II	ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0376-2020	Class II	ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0375-2020	Class II	ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0374-2020	Class II	ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0373-2020	Class II	ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY...	Orthofix SRL	JDW	2018-09-27
Z-0413-2019	Class II	Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY...	GE Healthcare	BSZ	2018-09-27
Z-0412-2019	Class II	Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X...	GE Healthcare	BSZ	2018-09-27
Z-0411-2019	Class II	Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO...	GE Healthcare	BSZ	2018-09-27
Z-0440-2019	Class II	INFUSE Bone Graft X SMALL KIT REF 7510100	Medtronic Sofamor Danek USA Inc	NEK	2018-09-27
Z-0783-2019	Class II	Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens...	Siemens Healthcare Diagnostics Inc.	JIT	2018-09-26
Z-0782-2019	Class II	Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens...	Siemens Healthcare Diagnostics Inc.	JIT	2018-09-26
Z-0781-2019	Class II	Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product...	Siemens Healthcare Diagnostics Inc.	JIT	2018-09-26