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-0170-2018 | Class II | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and... | Summit Medical, LLC | MUU | |
| Z-0075-2018 | Class II | HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest... | Terumo BCT, Ltd | FMF | |
| Z-0104-2018 | Class II | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE... | Terumo BCT, Ltd | JQC | |
| Z-0103-2018 | Class II | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical... | Terumo BCT, Ltd | JQC | |
| Z-1733-2018 | Class II | BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078 | Datascope Corp. | DWE | |
| Z-1732-2018 | Class II | BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 | Datascope Corp. | DTN | |
| Z-1731-2018 | Class II | BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 | Datascope Corp. | DTN | |
| Z-1730-2018 | Class II | BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 | Datascope Corp. | DTN | |
| Z-1729-2018 | Class II | BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504 | Datascope Corp. | DTN | |
| Z-1728-2018 | Class II | BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513 | Datascope Corp. | DTN | |
| Z-1727-2018 | Class II | ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 | Datascope Corp. | DTN | |
| Z-1726-2018 | Class II | BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 | Datascope Corp. | DTN | |
| Z-1725-2018 | Class II | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 | Datascope Corp. | DWE | |
| Z-1724-2018 | Class II | BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461 | Datascope Corp. | DTN | |
| Z-1723-2018 | Class II | BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 | Datascope Corp. | DTN | |
| Z-1722-2018 | Class II | BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434 | Datascope Corp. | DTN | |
| Z-1721-2018 | Class II | BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622 | Datascope Corp. | DTN | |
| Z-1720-2018 | Class II | BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02 | Datascope Corp. | DWE | |
| Z-1719-2018 | Class II | BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 | Datascope Corp. | DTN | |
| Z-1718-2018 | Class II | BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 | Datascope Corp. | DWE | |
| Z-1717-2018 | Class II | BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01 | Datascope Corp. | DWE | |
| Z-1716-2018 | Class II | BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No... | Datascope Corp. | DTN | |
| Z-1715-2018 | Class II | BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295 | Datascope Corp. | DTN | |
| Z-1714-2018 | Class II | BEQ-TOP 22701, Catalog No. 701050790 | Datascope Corp. | DTN | |
| Z-1713-2018 | Class II | BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 | Datascope Corp. | DTN | |
| Z-1712-2018 | Class II | BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179 | Datascope Corp. | DTN | |
| Z-1711-2018 | Class II | BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899 | Datascope Corp. | DTN | |
| Z-1710-2018 | Class II | BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752 | Datascope Corp. | DTN | |
| Z-1709-2018 | Class II | BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 | Datascope Corp. | DWE | |
| Z-1708-2018 | Class II | Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 | Datascope Corp. | DTN | |
| Z-1707-2018 | Class II | Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513 | Datascope Corp. | DTN | |
| Z-1706-2018 | Class II | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | Datascope Corp. | DTN | |
| Z-1211-2018 | Class II | 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. | MVN | |
| Z-1210-2018 | Class II | ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR | Johnson & Johnson Vision Care, Inc. | LPL | |
| Z-1209-2018 | Class II | ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS | Johnson & Johnson Vision Care, Inc. | LPM | |
| Z-0931-2018 | Class II | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System... | Ion Beam Applications S.A. | LHN | |
| Z-0832-2018 | Class II | Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous... | Cook Incorporated | KNT | |
| Z-0831-2018 | Class II | Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous... | Cook Incorporated | KNT | |
| Z-0830-2018 | Class II | Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the... | Cook Incorporated | KNT | |
| Z-0330-2018 | Class II | CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a... | Philips North America LLC | JAA | |
| Z-0086-2018 | Class II | NucliSENS Lysis Buffer Extended lot for RES 76675 | bioMerieux, Inc. | PPM | |
| Z-0085-2018 | Class II | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument... | Bioseal | KDD | |
| Z-0059-2018 | Class II | Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic... | Teleflex Medical | GEI | |
| Z-2617-2021 | Class II | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5... | Boston Scientific Corporation | N/A | |
| Z-0930-2018 | Class II | Proteus 235, graphite block 8 | Ion Beam Applications S.A. | LHN | |
| Z-0690-2018 | Class II | ARROW PICC powered by ARROW VPS Stylet | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | |
| Z-0658-2018 | Class II | ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MPB | |
| Z-0657-2018 | Class II | Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | |
| Z-0656-2018 | Class II | ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0655-2018 | Class II | AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ |