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-1296-2017 | Class II | Extremity Pack (1344), part number AMS6561 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1295-2017 | Class II | Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1294-2017 | Class II | ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1293-2017 | Class II | Dr. Newman Surgical Procedure Pack, part number PSS1689(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1292-2017 | Class II | Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E | Windstone Medical Packaging, Inc. | FSY | |
| Z-1291-2017 | Class II | Dr. Casey Pack, part number AMS4313(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1290-2017 | Class II | Dr Bragg Vein Tray - RX, part number 007912-8 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1289-2017 | Class II | D&C/Cysto Pack, part number PSS3257(D | Windstone Medical Packaging, Inc. | FSY | |
| Z-1288-2017 | Class II | D & C Pack, part number AMS4796(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1287-2017 | Class II | D & C Kit, part number CMP1466(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1286-2017 | Class II | Custom Venous Kit, part number TVS4024(C | Windstone Medical Packaging, Inc. | FSY | |
| Z-1285-2017 | Class II | Custom Pack - with Introducer Kit, part number TVS4011NI(L | Windstone Medical Packaging, Inc. | FSY | |
| Z-1284-2017 | Class II | Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1283-2017 | Class II | Custom Breast Augmentation Pack, part number PSS2455(D | Windstone Medical Packaging, Inc. | FSY | |
| Z-1282-2017 | Class II | C-Tray Pack, part number PSS2707(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1281-2017 | Class II | Chest Breast Drape, part number AMS5853 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1280-2017 | Class II | Catheter Pack, part number AMS4399(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1279-2017 | Class II | Brow Pack, part number PSS1785(C | Windstone Medical Packaging, Inc. | FSY | |
| Z-1278-2017 | Class II | Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1277-2017 | Class II | Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1276-2017 | Class II | Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1275-2017 | Class II | Bleph Pack, part number AMS3325(B | Windstone Medical Packaging, Inc. | FSY | |
| Z-1274-2017 | Class II | Bayview Breast Pack, part number 009080-2 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1273-2017 | Class II | Bayview Abdominoplasty Pack, part number 009079-1 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1272-2017 | Class II | Basin Pack, part number AMS2497 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1271-2017 | Class II | Basic Tray, part number PSS1559(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1270-2017 | Class II | Basic Setup Tray, part number AMS6414 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1269-2017 | Class II | Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1268-2017 | Class II | Basic Pack (1185), part number AMS6560 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1267-2017 | Class II | Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1266-2017 | Class II | Basic Kit, part number CMP1109(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1265-2017 | Class II | Basic Face Kit, part number PS517A(D | Windstone Medical Packaging, Inc. | FSY | |
| Z-1264-2017 | Class II | Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B | Windstone Medical Packaging, Inc. | FSY | |
| Z-1263-2017 | Class II | Augmentation Pack, part number AMS6370 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1262-2017 | Class II | Arthroscopy Pack, part number AMS6559 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1261-2017 | Class II | Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1260-2017 | Class II | Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1259-2017 | Class II | Angio Pack, part number AMS6711 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1200-2017 | Class II | VIDAS 3 software v. 1.1.4 | bioMerieux, Inc. | LFZ | |
| Z-1258-2017 | Class II | Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. | Windstone Medical Packaging, Inc. | FSY | |
| Z-1116-2017 | Class II | Syngo.plaza, picture archiving and communications system. | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-1118-2017 | Class II | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The... | Siemens Medical Solutions USA, Inc. | MUE | |
| Z-1227-2017 | Class II | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro... | Siemens Healthcare Diagnostics Inc. | LPS | |
| Z-1228-2017 | Class II | Vascular catheter introduction kit The PICC is indicated for short or long term... | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0705-2018 | Class II | Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation. | Teleflex Medical | CCW | |
| Z-1220-2017 | Class II | 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw | Zimmer GmbH | HWC | |
| Z-1256-2017 | Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1255-2017 | Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1254-2017 | Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2... | Siemens Healthcare Diagnostics Inc. | JJX | |
| Z-1191-2017 | Class II | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision... | Encore Medical, LP | KWA |