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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.

FDA Recall
Terminated ·GE Medical Systems, LLC·Product code JAA·April 16, 2009

Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·July 1, 2009

Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.

FDA Recall
Terminated ·Kentucky Packaging Service LP·Product code GEI·September 24, 2009

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

FDA Recall
Terminated ·Zimmer Inc.·Product code JWH·October 8, 2009

Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.

FDA Recall
Terminated ·Stryker Imaging·Product code LMB·July 31, 2009

Neos Vanadium Excavator Part Number 591/0 SCHE

FDA Recall
Terminated ·Sybron Dental Specialties·Product code EKC·November 14, 2008

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

FDA Recall
Terminated ·Zimmer Inc.·Product code JWH·October 8, 2009

Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.

FDA Recall
Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·August 11, 2009

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

FDA Recall
Terminated ·Zimmer Inc.·Product code JWH·October 8, 2009

Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1, BIOMET MICROFIXATION, INC., 150 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA Instrument used to pull up the broken bone, so it is flush and can be plated fixated. The Byrd screw is then removed.

FDA Recall
Terminated ·Biomet Microfixation, Inc.·Product code LXH·February 19, 2009