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 648 of 1191

FDA device recalls, page 648 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0147-2017	Class II	Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0146-2017	Class II	Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0145-2017	Class II	Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0144-2017	Class II	Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0143-2017	Class II	Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0142-2017	Class II	Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0141-2017	Class II	Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0140-2017	Class II	Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience...	Windstone Medical Packaging, Inc.	FSY	2015-04-22
Z-0104-2016	Class II	regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0103-2016	Class II	regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0102-2016	Class II	regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0101-2016	Class II	regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0100-2016	Class II	regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0099-2016	Class II	regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0098-2016	Class II	regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0097-2016	Class II	regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0096-2016	Class II	regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0095-2016	Class II	regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0094-2016	Class II	regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0093-2016	Class II	regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0092-2016	Class II	regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0091-2016	Class II	regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0090-2016	Class II	regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0089-2016	Class II	regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0088-2016	Class II	regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0087-2016	Class II	regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0086-2016	Class II	regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0085-2016	Class II	regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0084-2016	Class II	regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0083-2016	Class II	regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0082-2016	Class II	regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0081-2016	Class II	regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0080-2016	Class II	regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0079-2016	Class II	regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0078-2016	Class II	regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0077-2016	Class II	regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0076-2016	Class II	regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0075-2016	Class II	regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0074-2016	Class II	regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0073-2016	Class II	regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0072-2016	Class II	regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0071-2016	Class II	regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0070-2016	Class II	regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical kit...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0069-2016	Class II	regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0068-2016	Class II	regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0067-2016	Class II	regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0066-2016	Class II	regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0065-2016	Class II	regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0064-2016	Class II	regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22
Z-0063-2016	Class II	regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit containing cover...	Resource Optimization & Innovation, LLC	FSY	2015-04-22