Browse Device Recalls
19 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 19 FDA device recalls in 2008.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 28, 2008 | Navitrack System - OS Knee Universal, Stereotaxic instrument | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| Oct 13, 2008 | Quadra S Offset Broach Handle The offset broach handle is intended to atta... | Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potent... | Class II | Medacta Usa Inc |
| Oct 10, 2008 | GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certa... | GE initiated a correction to the instructions/use due to the potential for erroneous auto injecti... | Class II | GE OEC Medical Systems, Inc |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 36... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| Aug 28, 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 33... | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control M... | Class II | Sechrist Industries Inc |
| Jul 16, 2008 | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessor... | Distribution of a product that did not meet specifications. (labeling error) | Class II | SRI Surgical |
| Jul 1, 2008 | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended... | It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not ... | Class II | Regulatory Insight, Inc |
| Jun 20, 2008 | Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... | Class III | Orthosoft, Inc. dba Zimmer CAS |
| Jun 12, 2008 | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS... | Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments... | Class II | Ventana Medical Systems Inc |
| Jun 4, 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk o... | Class II | Orthosoft, Inc. dba Zimmer CAS |
| May 13, 2008 | TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanne... | The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis... | Class II | Toshiba American Medical Systems Inc |
| May 13, 2008 | Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is c... | Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannula... | Class II | Beevers Manufacturing & Supply, Inc. |
| May 13, 2008 | EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Ima... | The status display in the sequence queue window may not change from "Current" to "Done". | Class II | Toshiba American Medical Systems Inc |
| May 10, 2008 | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to p... | During two separate occasions an impactor plate on the handle broke off while being struck by a m... | Class II | SpineFrontier, Inc. |
| May 8, 2008 | Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To b... | The outer jacket is receding away from the black sensor prematurely. | Class II | SagaTech Electronics, Inc. |
| May 1, 2008 | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an auto... | Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, ... | Class II | Dako North America Inc. |
| May 1, 2008 | GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile install... | The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT s... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 27, 2008 | Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based c... | The systems all have a similar table control board. It has been found that this board may cause ... | Class II | Toshiba American Medical Systems Inc |
| Feb 22, 2008 | OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-ar... | Please be aware that this is not a new recall. The firm has taken action; but, due to administra... | Class I | GE OEC Medical Systems, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.