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 369 of 1190

FDA device recalls, page 369 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0626-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0625-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0624-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0623-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0622-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0621-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0620-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0619-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0618-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0617-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0616-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0615-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0614-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0613-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0896-2020	Class II	CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0895-2020	Class II	CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0894-2020	Class II	CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0893-2020	Class II	CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0892-2020	Class II	CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0891-2020	Class II	Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0890-2020	Class II	CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0889-2020	Class II	CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0888-2020	Class II	CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0887-2020	Class II	High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0886-2020	Class II	CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory...	Haemonetics Corporation	CAC	2019-10-21
Z-0885-2020	Class II	CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related...	Haemonetics Corporation	CAC	2019-10-21
Z-0560-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0559-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0558-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0557-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0556-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0555-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0554-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0553-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0552-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0551-2020	Class II	Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640	Boston Scientific Corporation	FGE	2019-10-21
Z-0550-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0549-2020	Class II	Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620	Boston Scientific Corporation	FGE	2019-10-21
Z-0548-2020	Class II	Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN...	Boston Scientific Corporation	FGE	2019-10-21
Z-0491-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0490-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0489-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0488-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0487-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0486-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0485-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0484-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0483-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0482-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21
Z-0481-2020	Class II	Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and...	Cook Incorporated	DQO	2019-10-21