510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,544 records, page 542 of 1191
FDA device recalls, page 542 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1346-2017Class IIMorris Lap Pack, part number PSS3199(AWindstone Medical Packaging, Inc.FSY
Z-1345-2017Class IIMorris Hysto Pack, part number PSS3198(AWindstone Medical Packaging, Inc.FSY
Z-1344-2017Class IIMinor/General/Ortho Pack, part number PSS3258(BWindstone Medical Packaging, Inc.FSY
Z-1343-2017Class IIMinor Tray, part number AMS2685Windstone Medical Packaging, Inc.FSY
Z-1342-2017Class IIMinor Procedure Pack, part number AMS4799Windstone Medical Packaging, Inc.FSY
Z-1341-2017Class IIMinor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part...Windstone Medical Packaging, Inc.FSY
Z-1340-2017Class IIMajor Pack (1345), part number AMS6565Windstone Medical Packaging, Inc.FSY
Z-1339-2017Class IIMajor Laparotomy Pack - NS, part number AMS4347Windstone Medical Packaging, Inc.FSY
Z-1338-2017Class IIMajor Kit, part number PHC1307(AWindstone Medical Packaging, Inc.FSY
Z-1337-2017Class IIMajor Breast Pack, part number AMS3409(BWindstone Medical Packaging, Inc.FSY
Z-1336-2017Class IILumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1335-2017Class IILower Extremity Pack, part number AMS4669Windstone Medical Packaging, Inc.FSY
Z-1334-2017Class IILiposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction...Windstone Medical Packaging, Inc.FSY
Z-1333-2017Class IILipo Pack, part AMS4420(AWindstone Medical Packaging, Inc.FSY
Z-1332-2017Class IILaparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy...Windstone Medical Packaging, Inc.FSY
Z-1331-2017Class IILaparoscopy Pack (1184), part number AMS6562Windstone Medical Packaging, Inc.FSY
Z-1330-2017Class IILaparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1329-2017Class IILap/Pelviscopy Pack, part number PSS3256(BWindstone Medical Packaging, Inc.FSY
Z-1328-2017Class IILap Pack, part number AMS4801Windstone Medical Packaging, Inc.FSY
Z-1327-2017Class IILap Minor Pack (1346), part number AMS6566Windstone Medical Packaging, Inc.FSY
Z-1326-2017Class IILap Gallbladder Pack, part number AMS3707Windstone Medical Packaging, Inc.FSY
Z-1325-2017Class IILap Chole Pack (6037) , part number AMS6567Windstone Medical Packaging, Inc.FSY
Z-1324-2017Class IILap Band Pack, part number AMS1785(AWindstone Medical Packaging, Inc.FSY
Z-1323-2017Class IILaminectomy Pack, part number PSS1844(BWindstone Medical Packaging, Inc.FSY
Z-1322-2017Class IIKnee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope...Windstone Medical Packaging, Inc.FSY
Z-1321-2017Class IIKnee Pack, part number AMS4211Windstone Medical Packaging, Inc.FSY
Z-1320-2017Class IIKnee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1319-2017Class IIHysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1318-2017Class IIHystero Pack, part number PSS3535(AWindstone Medical Packaging, Inc.FSY
Z-1317-2017Class IIHSG Pack, part number PSS3287Windstone Medical Packaging, Inc.FSY
Z-1316-2017Class IIHip Pack (1347), part number AMS6564Windstone Medical Packaging, Inc.FSY
Z-1315-2017Class IIHernia Pack, part number AMS3859Windstone Medical Packaging, Inc.FSY
Z-1314-2017Class IIHead/Neck Pack, part number AMS6121Windstone Medical Packaging, Inc.FSY
Z-1313-2017Class IIHead Pack, part number PSS1934(BWindstone Medical Packaging, Inc.FSY
Z-1312-2017Class IIHand Tray, part number PSS2365(F Hand Tray, part number PSS2365(GWindstone Medical Packaging, Inc.FSY
Z-1311-2017Class IIHand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1310-2017Class IIGYN Pack, part number AMS4013(AWindstone Medical Packaging, Inc.FSY
Z-1309-2017Class IIGYN Lap Pack, part number PSS2194(BWindstone Medical Packaging, Inc.FSY
Z-1308-2017Class IIGeneral Surgery Pack, part number PSS1380(AWindstone Medical Packaging, Inc.FSY
Z-1307-2017Class IIGeneral Plastics Pack, part number 008617-1Windstone Medical Packaging, Inc.FSY
Z-1306-2017Class IIGeneral Plastic Pack, part number PSS2432(AWindstone Medical Packaging, Inc.FSY
Z-1305-2017Class IIGeneral Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack...Windstone Medical Packaging, Inc.FSY
Z-1304-2017Class IIGeneral Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number...Windstone Medical Packaging, Inc.FSY
Z-1303-2017Class IIFoot Pack, part number AMS3637Windstone Medical Packaging, Inc.FSY
Z-1302-2017Class IIFacial Tray, part number PSS1558(AWindstone Medical Packaging, Inc.FSY
Z-1301-2017Class IIFacial Plastic Pack, part number AMS3327(CWindstone Medical Packaging, Inc.FSY
Z-1300-2017Class IIFacial Pack , part number AMS6501Windstone Medical Packaging, Inc.FSY
Z-1299-2017Class IIEye Tray, part number PSS1834 Eye Tray, part number PSS1834(AWindstone Medical Packaging, Inc.FSY
Z-1298-2017Class IIEye Plastic Tray, part number PSS1931(AWindstone Medical Packaging, Inc.FSY
Z-1297-2017Class IIExtremity Pack-N Brunswick, part number PSS1866(AWindstone Medical Packaging, Inc.FSY