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-2248-2013 | Class II | ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer... | Instrumentation Laboratory Co. | GKP | |
| Z-2247-2013 | Class II | ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer... | Instrumentation Laboratory Co. | GKP | |
| Z-2246-2013 | Class II | ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | |
| Z-2245-2013 | Class II | ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed... | Instrumentation Laboratory Co. | GKP | |
| Z-2244-2013 | Class II | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer... | Instrumentation Laboratory Co. | GKP | |
| Z-1995-2013 | Class II | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO... | Blue Belt Technologies MN | KKX | |
| Z-2045-2013 | Class II | Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the... | Medtronic, Inc. | OUT | |
| Z-1939-2013 | Class II | C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue... | Atrium Medical Corporation | FTL | |
| Z-1938-2013 | Class II | C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. | Atrium Medical Corporation | FTL | |
| Z-1937-2013 | Class II | C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies. | Atrium Medical Corporation | FTL | |
| Z-1936-2013 | Class II | C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies. | Atrium Medical Corporation | FTL | |
| Z-2095-2013 | Class II | PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-1959-2013 | Class II | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box... | Vital Signs, Inc. | FLL | |
| Z-1988-2013 | Class II | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free... | Aspen Surgical Products, Inc. | FPX | |
| Z-1507-2014 | Class II | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-1633-2014 | Class II | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0457-2014 | Class II | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS... | Abbott Medical | GCX | |
| Z-2106-2013 | Class II | Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing... | Medtronic, Inc. | DWF | |
| Z-2105-2013 | Class II | Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers... | Medtronic, Inc. | DTZ | |
| Z-2104-2013 | Class II | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2... | Medtronic, Inc. | DWE | |
| Z-1997-2013 | Class II | Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read... | Siemens Healthcare Diagnostics Inc. | KHE | |
| Z-2056-2013 | Class II | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The... | Integra Lifesciences Sales LLC | HBG | |
| Z-2090-2014 | Class III | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH)... | ZOLL Circulation, Inc. | DRM | |
| Z-0831-2014 | Class II | Brilliance iCT and Brilliance iCT SP These systems are intended to produce... | Philips North America LLC | JAK | |
| Z-2198-2013 | Class II | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the... | Assuramed | GJS | |
| Z-2197-2013 | Class II | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides... | Assuramed | KHE | |
| Z-2196-2013 | Class II | DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls... | Assuramed | JJW | |
| Z-0031-2014 | Class II | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during... | Aesculap Inc | GAD | |
| Z-0086-2014 | Class II | HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The... | HemoCue AB | KQO | |
| Z-1981-2013 | Class II | Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem... | Zimmer GmbH | JDG | |
| Z-2080-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2079-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2078-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2077-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2076-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2075-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2074-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2073-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2072-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2071-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2070-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2069-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2068-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2067-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2066-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2065-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2064-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2063-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2062-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT | |
| Z-2061-2013 | Class II | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem... | Waldemar Link GmbH & Co. KG (Corp. Hq.) | HWT |