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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.

Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.

FDA Recall
Terminated ·Monarch Labs, LLC·Product code NQK·May 3, 2009

Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd, Leeds, United Kingdom.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code KWA·March 5, 2010

Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

FDA Recall
Terminated ·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010

Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912

FDA Recall
Terminated ·Oridion Medical·Product code CCK·May 26, 2010

Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

FDA Recall
Terminated ·Alcon Research LTD dba Alcon Laboratories, Inc.·Product code HQC·April 30, 2010

Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number: 700304007, 700304010, 700304015, 700305007, 700305010, 7003015. 510k Exempt. Qty Dist. - 4,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Drainage Cather

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code JCY·September 1, 2009

Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code DTR·June 8, 2010

CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

FDA Recall
Terminated ·Veridex, LLC·Product code GKH·May 19, 2010