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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 496 of 1191

FDA device recalls, page 496 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0404-2018	Class II	daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical...	Intuitive Surgical, Inc.	NAY	2017-09-19
Z-0159-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0158-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0157-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0156-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0155-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0154-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0153-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0152-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0151-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0150-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0149-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0148-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0147-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0146-2018	Class II	Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .	Exactech, Inc.	JWH	2017-09-19
Z-0145-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0144-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0143-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0142-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0141-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .	Exactech, Inc.	JWH	2017-09-19
Z-0140-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0139-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0138-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0137-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0136-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0135-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0134-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile...	Exactech, Inc.	JWH	2017-09-19
Z-0133-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23...	Exactech, Inc.	JWH	2017-09-19
Z-0132-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile...	Exactech, Inc.	JWH	2017-09-19
Z-0131-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21...	Exactech, Inc.	JWH	2017-09-19
Z-0130-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0129-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile...	Exactech, Inc.	JWH	2017-09-19
Z-0128-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-0127-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile...	Exactech, Inc.	JWH	2017-09-19
Z-0126-2018	Class II	Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.	Exactech, Inc.	JWH	2017-09-19
Z-1180-2018	Class II	BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro...	Becton Dickinson & Co	JKA	2017-09-18
Z-0047-2018	Class II	Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel...	Siemens Medical Solutions USA, Inc.	KPS	2017-09-18
Z-0043-2018	Class II	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product...	Microport Orthopedics Inc.	HWC	2017-09-18
Z-1008-2018	Class II	36Mm Cocr Modular Hd -6Mm	Zimmer GmbH	JDI	2017-09-15
Z-0908-2018	Class II	Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with...	Medtronic, Inc.	GDW	2017-09-15
Z-0027-2018	Class II	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro...	Hologic, Inc.	NSU	2017-09-15
Z-0042-2018	Class II	EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product...	Encore Medical, LP	JWH	2017-09-15
Z-0041-2018	Class II	EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product...	Encore Medical, LP	JWH	2017-09-15
Z-0028-2018	Class II	Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse...	Cepheid	N/A	2017-09-15
Z-0192-2018	Class II	Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth...	Hill-Rom Manufacturing, Inc.	BYI	2017-09-15
Z-1309-2018	Class II	Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each...	C.R. Bard Inc	EZD	2017-09-14
Z-1308-2018	Class II	Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged...	C.R. Bard Inc	EZD	2017-09-14
Z-0506-2018	Class II	Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system...	Cardiovascular Systems Incorporated	MCW	2017-09-14
Z-0505-2018	Class II	Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system...	Cardiovascular Systems Incorporated	MCW	2017-09-14
Z-1307-2018	Class II	HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each...	C.R. Bard Inc	EZD	2017-09-14