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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.

Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.

FDA Recall
Terminated ·Boston Scientific Corp·Product code KNT·May 5, 2009

Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.

FDA Recall
Terminated ·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009

Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·April 16, 2009

Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code KWL·January 6, 2009

Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 6, 2009

Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·January 6, 2009

LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

FDA Recall
Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009

LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

FDA Recall
Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009

Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopaedics The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 17, 2006