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 , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0197-2017 | Class II | General Plastics Pack, Kit number 008617-1 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0196-2017 | Class II | General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0195-2017 | Class II | General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0194-2017 | Class II | General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0193-2017 | Class II | General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0192-2017 | Class II | General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0191-2017 | Class II | Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0190-2017 | Class II | Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0189-2017 | Class II | Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0188-2017 | Class II | Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0187-2017 | Class II | Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0186-2017 | Class II | Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0185-2017 | Class II | Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0184-2017 | Class II | Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0183-2017 | Class II | Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0182-2017 | Class II | ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0181-2017 | Class II | ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0180-2017 | Class II | Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0179-2017 | Class II | Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0178-2017 | Class II | Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0177-2017 | Class II | Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0176-2017 | Class II | Dr. Fetters Hand Pack, Kit number AMS3690 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0175-2017 | Class II | Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0174-2017 | Class II | Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0173-2017 | Class II | Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0172-2017 | Class II | DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0171-2017 | Class II | D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0170-2017 | Class II | D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0169-2017 | Class II | D & C Kit, Kit number CMP1466 and CMP1466(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0168-2017 | Class II | Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0167-2017 | Class II | Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0166-2017 | Class II | Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0165-2017 | Class II | Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0164-2017 | Class II | Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0163-2017 | Class II | Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0162-2017 | Class II | Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0161-2017 | Class II | Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0160-2017 | Class II | C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0159-2017 | Class II | C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0158-2017 | Class II | C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0157-2017 | Class II | Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0156-2017 | Class II | Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0155-2017 | Class II | Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0154-2017 | Class II | Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0153-2017 | Class II | Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0152-2017 | Class II | Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0151-2017 | Class II | Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0150-2017 | Class II | Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0149-2017 | Class II | Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0148-2017 | Class II | Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY |