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-0247-2017 | Class II | Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0246-2017 | Class II | Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0245-2017 | Class II | Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0244-2017 | Class II | Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0243-2017 | Class II | Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0242-2017 | Class II | Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0241-2017 | Class II | Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0240-2017 | Class II | Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0239-2017 | Class II | Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0238-2017 | Class II | Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0237-2017 | Class II | Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0236-2017 | Class II | Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0235-2017 | Class II | Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0234-2017 | Class II | Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0233-2017 | Class II | Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0232-2017 | Class II | Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0231-2017 | Class II | Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0230-2017 | Class II | Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0229-2017 | Class II | Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0228-2017 | Class II | Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0227-2017 | Class II | Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0226-2017 | Class II | Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0225-2017 | Class II | Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0224-2017 | Class II | Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0223-2017 | Class II | Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0222-2017 | Class II | Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0221-2017 | Class II | Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0220-2017 | Class II | Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0219-2017 | Class II | Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0218-2017 | Class II | Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0217-2017 | Class II | Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0216-2017 | Class II | Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0215-2017 | Class II | Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0214-2017 | Class II | Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0213-2017 | Class II | Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0212-2017 | Class II | Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0211-2017 | Class II | Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0210-2017 | Class II | Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0209-2017 | Class II | HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0208-2017 | Class II | Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0207-2017 | Class II | Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0206-2017 | Class II | Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0205-2017 | Class II | Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0204-2017 | Class II | Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0203-2017 | Class II | Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0202-2017 | Class II | GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0201-2017 | Class II | GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0200-2017 | Class II | GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0199-2017 | Class II | GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0198-2017 | Class II | General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY |