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-1858-2015 | Class II | Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062 | Medtronic, Inc. | NYU | |
| Z-1857-2015 | Class II | Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508 | Medtronic, Inc. | NYU | |
| Z1856-2015 | Class II | Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458 | Medtronic, Inc. | NYU | |
| Z1855-2015 | Class II | Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408 | Medtronic, Inc. | NYU | |
| Z-1854-2015 | Class II | Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 | Medtronic, Inc. | NYU | |
| Z-1853-2015 | Class II | Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 | Medtronic, Inc. | NYU | |
| Z-1852-2015 | Class II | Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 | Medtronic, Inc. | NYU | |
| Z-1851-2015 | Class II | Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063 | Medtronic, Inc. | NYU | |
| Z-1850-2015 | Class II | Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI... | Medtronic, Inc. | NYU | |
| Z-0288-2017 | Class II | Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0287-2017 | Class II | Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0286-2017 | Class II | Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0285-2017 | Class II | Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0284-2017 | Class II | Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0283-2017 | Class II | Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0282-2017 | Class II | Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0281-2017 | Class II | Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0280-2017 | Class II | Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0279-2017 | Class II | Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0278-2017 | Class II | Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0277-2017 | Class II | Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0276-2017 | Class II | Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0275-2017 | Class II | Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0274-2017 | Class II | Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0273-2017 | Class II | Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0272-2017 | Class II | Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0271-2017 | Class II | Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0270-2017 | Class II | Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0269-2017 | Class II | Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0268-2017 | Class II | Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0267-2017 | Class II | Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0266-2017 | Class II | Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0265-2017 | Class II | Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0264-2017 | Class II | Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0263-2017 | Class II | Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0262-2017 | Class II | Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0261-2017 | Class II | Plastic General Pack, Kit number AMS4215 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0260-2017 | Class II | Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0259-2017 | Class II | Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0258-2017 | Class II | Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0257-2017 | Class II | Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0256-2017 | Class II | Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0255-2017 | Class II | Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0254-2017 | Class II | Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0253-2017 | Class II | Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0252-2017 | Class II | Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0251-2017 | Class II | Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0250-2017 | Class II | OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0249-2017 | Class II | Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general... | Windstone Medical Packaging, Inc. | FSY | |
| Z-0248-2017 | Class II | Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in... | Windstone Medical Packaging, Inc. | FSY |
