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 645 of 1191
FDA device recalls, page 645 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1858-2015Class IIPalindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062Medtronic, Inc.NYU
Z-1857-2015Class IIPalindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508Medtronic, Inc.NYU
Z1856-2015Class IIPalindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458Medtronic, Inc.NYU
Z1855-2015Class IIPalindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408Medtronic, Inc.NYU
Z-1854-2015Class IIPalindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064Medtronic, Inc.NYU
Z-1853-2015Class IIPalindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064Medtronic, Inc.NYU
Z-1852-2015Class IIPalindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064Medtronic, Inc.NYU
Z-1851-2015Class IIPalindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063Medtronic, Inc.NYU
Z-1850-2015Class IIPalindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI...Medtronic, Inc.NYU
Z-0288-2017Class IIPort Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0287-2017Class IIMohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits...Windstone Medical Packaging, Inc.FSY
Z-0286-2017Class IILaparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for...Windstone Medical Packaging, Inc.FSY
Z-0285-2017Class IIDr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0284-2017Class IIVirginia Custom Pack, Kit number RMS1744 convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0283-2017Class IIVein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery...Windstone Medical Packaging, Inc.FSY
Z-0282-2017Class IIVaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0281-2017Class IIUpper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery...Windstone Medical Packaging, Inc.FSY
Z-0280-2017Class IIUpper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for...Windstone Medical Packaging, Inc.FSY
Z-0279-2017Class IIUniversal Pack, Kit number AMS2036 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0278-2017Class IITransvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery...Windstone Medical Packaging, Inc.FSY
Z-0277-2017Class IITotal Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery...Windstone Medical Packaging, Inc.FSY
Z-0276-2017Class IITotal Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for...Windstone Medical Packaging, Inc.FSY
Z-0275-2017Class IITotal Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0274-2017Class IITaymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery...Windstone Medical Packaging, Inc.FSY
Z-0273-2017Class IISurgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0272-2017Class IIStudent Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0271-2017Class IISpine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0270-2017Class IIShoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638...Windstone Medical Packaging, Inc.FSY
Z-0269-2017Class IIShoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609...Windstone Medical Packaging, Inc.FSY
Z-0268-2017Class IISet-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0267-2017Class IISet Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0266-2017Class IIRobotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0265-2017Class IIPodiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits...Windstone Medical Packaging, Inc.FSY
Z-0264-2017Class IIPodiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for...Windstone Medical Packaging, Inc.FSY
Z-0263-2017Class IIPlastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0262-2017Class IIPlastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0261-2017Class IIPlastic General Pack, Kit number AMS4215 convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0260-2017Class IIPeri Kit, Kit number PSS1037 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0259-2017Class IIPeri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0258-2017Class IIPercutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used...Windstone Medical Packaging, Inc.FSY
Z-0257-2017Class IIPelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0256-2017Class IIPacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0255-2017Class IIOrtho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0254-2017Class IIOrtho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0253-2017Class IIOrtho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0252-2017Class IIOpen Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0251-2017Class IIOcular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for...Windstone Medical Packaging, Inc.FSY
Z-0250-2017Class IIOB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY
Z-0249-2017Class IINewport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general...Windstone Medical Packaging, Inc.FSY
Z-0248-2017Class IINasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in...Windstone Medical Packaging, Inc.FSY