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-0460-2014 | Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non... | Zimmer GmbH | FZX | |
| Z-0459-2014 | Class II | NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non... | Zimmer GmbH | FZX | |
| Z-0743-2014 | Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with... | Atrium Medical Corporation | CAC | |
| Z-0742-2014 | Class II | Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product... | Atrium Medical Corporation | CAC | |
| Z-0741-2014 | Class II | Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest... | Atrium Medical Corporation | CAC | |
| Z-0740-2014 | Class II | Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest... | Atrium Medical Corporation | CAC | |
| Z-0739-2014 | Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual... | Atrium Medical Corporation | CAC | |
| Z-0738-2014 | Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual... | Atrium Medical Corporation | CAC | |
| Z-0737-2014 | Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with... | Atrium Medical Corporation | CAC | |
| Z-0736-2014 | Class II | Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line... | Atrium Medical Corporation | CAC | |
| Z-0735-2014 | Class II | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with... | Atrium Medical Corporation | CAC | |
| Z-1089-2016 | Class II | IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part... | Cmp Industries, LLC | EBI | |
| Z-1469-2014 | Class II | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided... | Brainlab, Inc. | HAW | |
| Z-0552-2014 | Class II | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and... | Varian Medical Systems, Inc. | MUJ | |
| Z-0486-2014 | Class I | FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100... | Abbott Medical | NBW | |
| Z-0485-2014 | Class I | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6... | Abbott Medical | NBW | |
| Z-0399-2014 | Class II | Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt... | Medtronic Neurosurgery | JXG | |
| Z-0398-2014 | Class II | Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog... | Medtronic Neurosurgery | JXG | |
| Z-0397-2014 | Class II | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized... | Medtronic Neurosurgery | JXG | |
| Z-0423-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0422-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | LXH | |
| Z-0421-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | LXH | |
| Z-0420-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0419-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0418-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0417-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0416-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch... | Depuy Orthopaedics Inc. | JWH | |
| Z-0415-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch... | Depuy Orthopaedics Inc. | JWH | |
| Z-0414-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0413-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-0412-2014 | Class II | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee... | Depuy Orthopaedics Inc. | JWH | |
| Z-1150-2014 | Class II | Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile... | Shimadzu Medical Systems | IZL | |
| Z-0853-2014 | Class II | GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging... | GE Healthcare | IZI | |
| Z-0907-2014 | Class II | Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0967-2014 | Class II | BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided... | Brainlab, Inc. | HAW | |
| Z-0521-2014 | Class II | Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si... | Intuitive Surgical, Inc. | NAY | |
| Z-0520-2014 | Class II | Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si... | Intuitive Surgical, Inc. | NAY | |
| Z-0516-2014 | Class II | HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 | Instrumentation Laboratory Co. | GGN | |
| Z-0515-2014 | Class II | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 | Instrumentation Laboratory Co. | GGN | |
| Z-0514-2014 | Class II | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 | Instrumentation Laboratory Co. | GGN | |
| Z-1068-2014 | Class II | Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy... | Smith & Nephew, Inc. | OMP | |
| Z-1067-2014 | Class II | Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | OMP | |
| Z-0482-2014 | Class II | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total... | Accumetrics, Inc. | JOZ | |
| Z-0528-2015 | Class II | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo... | Concentric Medical, Inc. | NRY | |
| Z-0622-2014 | Class II | Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra... | Integra LifeSciences Corporation | JXG | |
| Z-0621-2014 | Class II | Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra... | Integra LifeSciences Corporation | JXG | |
| Z-0606-2014 | Class II | RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized... | Instrumentation Industries, Incorporated | CAI | |
| Z-0527-2014 | Class II | Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. "... | Karl Storz Endoscopy-America, Inc. | ECQ | |
| Z-0526-2014 | Class II | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1... | Karl Storz Endoscopy-America, Inc. | CAL | |
| Z-0641-2014 | Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with... | Ansell Sandel Medical Solutions LLC | GDZ |