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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.

BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation

FDA Recall
Terminated ·Biopro, Inc.·Product code JDI·September 21, 2011

CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; b) Tubing Extension Sets and IV Sets component C-FG711297CP, vendor pn FG711297CP; component C-FG711093CP, vendor pn FG711093CP; component C-FG711298CP, vendor pn FG711298CP; component C-FG711092CP, vendor pn FG711092CP; c) Cast Padding component C-9046, vendor pn 9046; component C-9044, vendor pn 9044; component C-9043, vendor pn 9043; component C-9062, vendor pn 9062; d) Scalpel Holder component C-DD1628-6, vendor pn DD1628-6; e) Latex Tubing component C-806-12, vendor pn 806-12; component C-808R, vendor pn 808R; component C-606R, vendor pn 606R; component C-122BA10, vendor pn 122BA10; component C-122BA12, vendor pn 122BA12; component C-122BA07, vendor pn 122BA07; component C-102BA12, vendor pn 102BA12; component C-099BA10, vendor pn 099BA10; component C-102BA10, vendor pn 102BA10; component C-103BA10, vendor pn 103BA10; component C-124BA10, vendor pn 124BA10; component C-140BA10, vendor pn 140BA10; f) Clinic Dropper component C-12548, vendor pn 10-871-00; g) Tongue Blade (depressor) component C-11820-010, vendor pn 07-920-00; h) Catheter Clamp component C-043-0497, vendor pn 033403-887; i) Gillette Good News Razor component C-P4417A, vendor pn 4417GN; j) Prepsicle Round Short Blue Swabstick component C-051-0401, vendor pn SBR20035; k) Tubing component C-SFM3-3050, vendor pn SFM3-3050; component C-SFM3-3650, vendor pn SFM3-3650; l) Specimen Container component C-B9021YN, vendor pn B9021YN; component C-C8846-18, vendor pn 15706-806; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

FDA Recall
Terminated ·Cardinal Health·Product code LRO·September 3, 2011

Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo Cardiovascular Systems, Ashland, MA 0172 Item Number: 71038-05 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***". Cutting and shaping bone including bones of the spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBC·March 17, 2011

Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FCG·August 11, 2011

Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated Perfusion Pack Item Number: 72941 Terumo Cardiovascular Systems, Ashland, MA 01721 The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011

Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

FDA Recall
Terminated ·Synthes USA (HQ), Inc.·Product code NKB·March 11, 2011

Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item Number: 73381 Terumo Cardiovascular Systems Corp. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it. The 3-T L. V. Control Valve is a one-way vent valve used during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde now and air into the heart.

FDA Recall
Terminated ·Terumo Cardiovascular Systems Corp·Product code MJJ·August 11, 2011