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-1562-05 | BD DTX Plus, Custom single-line neonatal pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1561-05 | BD DTX Plus, 12'' single-line neonatal pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1560-05 | BD DTX Plus, Stand-alone pressure transducer with 3cc/hr flush device | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1559-05 | BD DTX Plus, 72'' complete single-line pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1558-05 | BD DTX Plus, 60'' complete dual-line pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-1557-05 | BD DTX Plus, 60'' complete single-line pressure monitoring kit. | Becton Dickinson Infusion Therapy Systems Inc. | DXN | ||
| Z-0371-06 | Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number... | Smith & Nephew, Inc. | LXH | ||
| Z-0988-2014 | Class II | Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid... | Siemens Hearing Instruments, Inc. | LEZ | |
| Z-0152-06 | BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use | Becton Dickinson & Co | GES | ||
| Z-1098-05 | ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 7 French... | Medtronic, Inc. | LJS | ||
| Z-1097-05 | ChemoSIte Cathteter Introducer Kit with 7 French Peel-Away Sheath Catalog Number: 120089 | Medtronic, Inc. | LJS | ||
| Z-1096-05 | ChemoSite Implantable venous access sytem with printed silicone Catheter and 9 French... | Medtronic, Inc. | LJS | ||
| Z-1095-05 | ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French... | Medtronic, Inc. | LJS | ||
| Z-1094-05 | ChemoSite Catheter Introducer Kit with 9 French Peel-Away Sheath Catalog Number: 120039 | Medtronic, Inc. | LJS | ||
| Z-1093-05 | ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9... | Medtronic, Inc. | LJS | ||
| Z-1092-05 | ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with... | Medtronic, Inc. | LJS | ||
| Z-1091-05 | ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with... | Medtronic, Inc. | LJS | ||
| Z-0890-05 | Hitachi AIRIS Elite Magnetic Resonance Imaging Device | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0889-05 | Hitachi AIRIS II Magnetic Resonance Imaging Device | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-0888-05 | Hitachi Altaire Magnetic Resonance Imaging Device. | FUJIFILM Healthcare Americas Corporation | LNH | ||
| Z-1067-05 | Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured... | Medtronic Powered Surgical Solutions | HBB | ||
| Z-0090-06 | Premicath 28G PICC Catheter | Vygon U.S.A. | LJS | ||
| Z-1539-05 | XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott... | Abbott Medical | DIF | ||
| Z-0985-05 | Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing... | Bio-Logic Systems Corp. | ETY | ||
| Z-1081-05 | Labeling is as follows: Product labeling: ''***Argon Medical Devices***RE-ORDER NO./REF... | Argon Medical Devices, Inc | IZI | ||
| Z-1080-05 | Labeling is as follows: Product Labeling: ''***Argon Medical Devices***12cc Control... | Argon Medical Devices, Inc | IZI | ||
| Z-1459-05 | Hemashield Vantage Vascular Graft. Vascular graft prosthesis. | Boston Scientific Corporation | DSY | ||
| Z-1079-05 | Labeling is as follows: Product Labeling: ''***Argon Medical Devices***MANIFOLD... | Argon Medical Devices, Inc | IZI | ||
| Z-1078-05 | Product consists of a syringe used to inject fluids during an angiographic procedure for... | Argon Medical Devices, Inc | IZI | ||
| Z-1077-05 | Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD... | Argon Medical Devices, Inc | IZI | ||
| Z-1076-05 | Product consists of a syringe used to inject fluids during an angiographic procedure for... | Argon Medical Devices, Inc | IZI | ||
| Z-0012-06 | EBI Trochanteric 11mm Long Nail. | Ebi, LLC | JDS | ||
| Z-0953-05 | CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no... | Boston Scientific Corporation | NIK | ||
| Z-0952-05 | CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D... | Boston Scientific Corporation | NIK | ||
| Z-0951-05 | CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE... | Boston Scientific Corporation | NIK | ||
| Z-0950-05 | CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no... | Boston Scientific Corporation | NIK | ||
| Z-0949-05 | CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model... | Boston Scientific Corporation | NIK | ||
| Z-1074-05 | ASY, Brat 2 Procedure Set | LivaNova USA, Inc. | CAC | ||
| Z-1073-05 | ASY Brat 2 Procedure Set | LivaNova USA, Inc. | CAC | ||
| Z-1072-05 | ASY, Brat Pack Procedure Set | LivaNova USA, Inc. | CAC | ||
| Z-1071-05 | ASY Brat 2 Procedure Set | LivaNova USA, Inc. | CAC | ||
| Z-1070-05 | ASY, Brat 2 Pack Procedure Set | LivaNova USA, Inc. | CAC | ||
| Z-1069-05 | ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. | LivaNova USA, Inc. | CAC | ||
| Z-1042-05 | Healing Labs Rite Choice Pregnancy Test Kit, packed in a cellophane display box... | Core Brands | LCX | ||
| Z-1040-05 | Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E | Siemens Healthcare Diagnostics Inc. | GHH | ||
| Z-1019-05 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... | Baxter Healthcare Renal Div | FKX | ||
| Z-1018-05 | HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... | Baxter Healthcare Renal Div | FKX | ||
| Z-1422-05 | STA-R blood coagulation analyzer. Catalog Number 57160. | Diagnostica Stago, Inc. | JPA | ||
| Z-1372-05 | DL 2000 Data Manager | Siemens Healthcare Diagnostics Inc. | JQP | ||
| Z-0993-05 | Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. | Warsaw Orthopedic, Inc. | HRX |