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-0932-2018 | Class II | 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit... | Cypress Medical Products LLC | N/A | |
| Z-0938-2018 | Class II | Proteus 235, Proton Therapy System a medical device designed to produce and delivers a... | Ion Beam Applications S.A. | LHN | |
| Z-1315-2018 | Class II | IntelliVue X3 Patient Monitor. | Philips North America LLC | MHX | |
| Z-0289-2018 | Class II | TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system... | Accuray Incorporated | IYE | |
| Z-0288-2018 | Class II | TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is... | Accuray Incorporated | IYE | |
| Z-0287-2018 | Class II | TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system... | Accuray Incorporated | IYE | |
| Z-0286-2018 | Class II | Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment... | Accuray Incorporated | IYE | |
| Z-0835-2018 | Class II | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC... | Stryker Corp. | GCJ | |
| Z-0323-2018 | Class II | Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris... | CareFusion 303, Inc | MEA | |
| Z-0322-2018 | Class II | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris... | CareFusion 303, Inc | FRN | |
| Z-1927-2018 | Class II | ALM XTEN Surgical Light intended to provide visible illumination for the surgical field... | Getinge US Sales LLC | FSY | |
| Z-0320-2018 | Class II | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink... | Brainlab, Inc. | HAW | |
| Z-0196-2019 | Class II | Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in... | Medacta USA, Inc. | LZO | |
| Z-0324-2018 | Class II | Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the... | Cordis US Corp. | FGE | |
| Z-0283-2018 | Class II | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra... | Implant Direct Sybron Manufacturing LLC | NDP | |
| Z-1166-2018 | Class II | ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1165-2018 | Class II | Pressure Injectable Multi- Lumen CVC Kit | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1164-2018 | Class II | Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1163-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1162-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1161-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1160-2018 | Class II | Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-1159-2018 | Class II | Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1158-2018 | Class II | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | |
| Z-0379-2018 | Class II | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting... | Carl Zeiss Metrology Inc | RCE | |
| Z-0418-2018 | Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25... | Alere San Diego, Inc. | DKZ | |
| Z-2255-2018 | Class II | VNS Therapy Programmer, Model 3000, v1.0 System | LivaNova USA, Inc. | MUZ | |
| Z-1136-2018 | Class II | Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated... | Abbott Medical | FRN | |
| Z-1316-2018 | Class II | HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. | Lifeline Systems, Inc. | ILQ | |
| Z-1135-2018 | Class II | Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated... | Abbott Medical | FRN | |
| Z-1134-2018 | Class II | Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated... | Abbott Medical | FRN | |
| Z-0239-2018 | Class II | Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical... | Spinal Elements, Inc | KWQ | |
| Z-2243-2018 | Class II | CritiCore Automated Urine Output and Temperature Monitor | C.R. Bard Inc | EXS | |
| Z-1366-2018 | Class II | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s... | Siemens Healthcare Diagnostics Inc. | KQO | |
| Z-1132-2018 | Class II | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One | NxStage Medical Inc | KPO | |
| Z-0924-2018 | Class II | Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. | Wiener Laboratories | MIU | |
| Z-0391-2018 | Class II | Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by... | Philips North America LLC | JAK | |
| Z-0390-2018 | Class II | Ingenuity Core, (Code 728321) Intended to produce images of the head and body by... | Philips North America LLC | JAK | |
| Z-0389-2018 | Class II | Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer... | Philips North America LLC | JAK | |
| Z-0388-2018 | Class II | Brilliance iCT Intended to produce images of the head and body by computer... | Philips North America LLC | JAK | |
| Z-0565-2018 | Class II | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine... | C.R. Bard Inc | EXS | |
| Z-0702-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-0701-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-0700-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-0699-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-0698-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-0697-2018 | Class II | MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with... | Zevex, Inc. | FPA | |
| Z-1255-2018 | Class II | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI... | Stryker Corp. | LXH | |
| Z-1254-2018 | Class II | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2... | Stryker Corp. | HRX | |
| Z-1253-2018 | Class II | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830... | Stryker Corp. | NDN |