The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

301–400 of 766

  • ModerateFDA (Drugs)·D-1460-2016·2016-08-24

    Zydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures

    Zydus Pharmaceuticals is recalling 223,776 bottles of Venlafaxine Hydrochloride ER capsules because retained samples failed dissolution specifications.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2426-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defect

    Biomet 3i is recalling specific lots of O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Conical 25 degree Angled Abutment Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Conical 25 degree Angled Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2016·2016-08-24

    Biomet 3i Recalls Straight Healing Abutments Due to Sealing Defects

    Biomet 3i is recalling specific dental implant abutments because pouches may not have been sealed during packing.

    Product
    Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2413-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implant copings because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2016·2016-08-24

    Biomet 3i Recalls Conical EP Healing Caps Due to Sealing Defects

    Biomet 3i, LLC is recalling Conical EP Healing Caps for dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Healing Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2409-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Defects

    Biomet 3i is recalling specific Gingihue dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2016·2016-08-24

    Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Preformance 15 degrees Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Preformance 15 degrees Pre-Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Twist Lock TM Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2419-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling Gingihue 15 degrees Pre-Angled Post dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2557-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2459-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling DAL-RO Housing, Female Assembly dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Housing, Female Assembly Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2579-2016·2016-08-24

    GE Centricity PACS Workstation Recalled for Image Grouping Errors

    GE Healthcare is recalling 498 Centricity PACS Workstations due to a software defect that causes random image-series grouping errors when specific exams are opened simultaneously.

    Product
    GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 EP Pick-Up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Pick-Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2490-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Pick-up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 332 Valleylab Laparoscopic Flat L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2016·2016-08-24

    Biomet 3i Recalls EP Healing Abutments Due to Unsealed Pouches

    Biomet 3i is recalling specific EP Healing Abutments because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2501-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2550-2016·2016-08-24

    Resmed Recalls 42 Quattro Air FFM Masks Due to Sizing and Venting Errors

    Resmed is recalling 42 Quattro Air FFM masks labeled as Medium vented but containing Large non-vented masks.

    Product
    Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2549-2016·2016-08-24

    Mindray Passport Series Patient Monitor CO2 Module Recall

    Mindray is recalling Passport Series Patient Monitor CO2 Modules due to a potential leakage issue with the Dryline II Water Trap.

    Product
    Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2016·2016-08-24

    Hospira Recalls Receptal Liners Due to Potential Suction Failure

    Hospira is recalling Receptal liners because using incorrect sizes with canisters may prevent the lid from fitting properly, resulting in insufficient or inconsistent vacuum suction.

    Product
    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2562-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach that could compromise the package integrity.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2016·2016-08-24

    Biomet 3i Recalls Gingihue Post Dental Implants Due to Sealing Defects

    Biomet 3i is recalling Gingihue Post Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2016·2016-08-24

    Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Gingihue 15 Degree Pre-Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·073-2016·2016-08-24

    Green Bay Dressed Beef Recalls Beef Brains Due to Specified Risk Materials

    Green Bay Dressed Beef, LLC is recalling approximately 7,420 pounds of beef brain products that may be contaminated with specified risk materials (SRM). The products were shipped to a distributor in California.

    Product
    Green Bay Dressed Beef, LLC — Green Bay Dressed Beef Recalls Beef Products Due To Possible Specified Risk Materials Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2410-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling specific Gingihue dental implants because their pouches may not have been sealed during packing.

    Product
    Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2437-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

    Biomet 3i is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Healing Abutment Dental Implants because pouches may not have been sealed during packing.

    Product
    Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2411-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i, LLC is recalling specific Gingihue Post dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling specific dental implant abutments because the packaging pouches may not have been sealed during packing.

    Product
    Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing.

    Product
    Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Pick-Up Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Standard Abutment Pick -Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2573-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Prep-Tite Post Dental implants because pouches may not have been sealed during packing.

    Product
    Prep-Tite Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Dental Implants Due to Sealing Issues

    Biomet 3i, LLC is recalling certain Gingihue 15 degree Pre-Angled Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue 15 degree Pre- Angled Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2561-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Spatula Electrode Recall for Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Straight Spatula Electrodes due to a potential sterile barrier breach. The recall affects 13,516 units distributed worldwide.

    Product
    Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2497-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling specific dental implants because their pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Straight Pick Up Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2536-2016·2016-08-24

    Stryker AutoPlex System Recalled Due to Piston Head Separation Risk

    Stryker is recalling AutoPlex System kits because the piston head may separate, blocking the valve and causing cement backflow toward the injector handle.

    Product
    Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2478-2016·2016-08-24

    Biomet 3i Recalls IOL Titanium Temporary Cylinder Dental Implants

    Biomet 3i, LLC is recalling IOL Titanium Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    IOL Titanium Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2016·2016-08-24

    Biomet 3i Recalls Dental Implant O-Ring Abutments Due to Sealing Defects

    Biomet 3i is recalling specific O-Ring Abutments for dental implants because pouches may not have been sealed during packing.

    Product
    O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2560-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic AP Argon Blunt Needle Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2499-2016·2016-08-24

    Biomet 3i Recalls Temporary Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 temporary dental implants because their packaging pouches may not have been sealed during packing.

    Product
    Certain Temporary Non-Hexed Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2406-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 EP Healing Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2016·2016-08-24

    Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Defects

    Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing. The recall covers 1,648,273 units distributed worldwide.

    Product
    Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2483-2016·2016-08-24

    Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defects

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Certain Implant Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2016·2016-08-24

    Bard TruGuide Biopsy Needle Recall for Incorrect Stylet Configuration

    Bard Peripheral Vascular Inc is recalling 1,250 TruGuide Disposable Coaxial Biopsy Needles because some units may contain two trocar or two blunt tip stylets instead of one of each.

    Product
    Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2516-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws because pouches may not have been sealed during packing.

    Product
    Certain Cover Screw Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Non-Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling DAL-RO Threaded Female Dental implants because pouches may not have been sealed during packing.

    Product
    DAL-RO Threaded Female Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2568-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 6,720 Valleylab Laparoscopic Straight Spatula Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2484-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling 1,648,273 Implant EP Twist Lock Coping Dental Implants because pouches may not have been sealed during packing.

    Product
    Certain Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2482-2016·2016-08-24

    Biomet 3i Recalls Hex Try-in Screws Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Hex Try-in Screws because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Hex Try-in Screw (5 pk) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2429-2016·2016-08-24

    Biomet 3i Recalls Locator Extra Light Retention Dental Implant Pouches

    Biomet 3i is recalling Locator Extra Light Retention Males dental implant pouches because they may not have been sealed during packing.

    Product
    Locator Extra Light Retention Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2016·2016-08-24

    Biomet 3i Recalls Locator Replacement Housing Dental Implants

    Biomet 3i, LLC is recalling Locator Replacement Housing dental implants because pouches may not have been sealed during packing.

    Product
    Locator Replacement Housing Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2493-2016·2016-08-24

    Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants

    Biomet 3i, LLC is recalling Preformance Temporary Cylinder Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Preformance Temporary Cylinder Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2430-2016·2016-08-24

    Biomet 3i Recalls Locator Light Retention Dental Implant Components

    Biomet 3i is recalling Locator Light Retention Replacement Males because pouches may not have been sealed during packing.

    Product
    Locator Light Retention Replacement Males 4pk Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2512-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Certain Bellatek Encode Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2511-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2471-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implant devices because pouches may not have been sealed during packing.

    Product
    Implant EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2538-2016·2016-08-24

    Telefax Medical Recalls Weck EFx Fascial Closure System for Labeling Error

    Teleflex Medical is recalling 45 units of the Weck EFx Classic Fascial Closure System because incorrect expiration dates were printed on the labels.

    Product
    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2438-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.

    Product
    Prep-tite Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2453-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Conical EP Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Conical EP Pick-Up Coping (Hexed) Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2580-2016·2016-08-24

    Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2414-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2446-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Transfer Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Standard Abutment Transfer Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2523-2016·2016-08-24

    Biomet 3i Recalls Certain Gingihue Post Dental Implants

    Biomet 3i is recalling certain Gingihue Post Dental implants because pouches may not have been sealed during packing.

    Product
    Certain Gingihue Post Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2434-2016·2016-08-24

    Biomet 3i Recalls Pick-Up Impression Coping Dental Implants

    Biomet 3i is recalling Pick-Up Impression Coping dental implants because pouches may not have been sealed during packing.

    Product
    Pick-Up Impression Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V613000·2016-08-23

    Jumping Jack Recalls 2014-2015 Utility Trailers Due to Axle Defect

    Jumping Jack is recalling 2014-2015 utility trailers because a small torsion arm may detach, causing loss of stability and increasing crash risk.

    Product
    JUMPING JACK — JUMPING JACK UTILITY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V614000·2016-08-23

    Land Rover Recalls Vehicles for Transmission Shift to Neutral Risk

    Land Rover is recalling certain 2014-2015 Range Rover Evoque and 2015 Discovery Sport vehicles because the transmission may unexpectedly shift to neutral, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16248·2016-08-23

    ALEX Toys Recalls Infant Building Sets Due to Choking Hazard

    ALEX Toys is recalling three infant building sets because small parts can detach, posing a choking hazard to young children.

    Product
    ALEX Jr. Baby Builder, First Pops and First Snaps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16247·2016-08-23

    McDonald's Recalls Step-iT Activity Wristbands Due to Skin Irritation Risk

    McDonald's is recalling Step-iT activity wristbands because they can cause skin irritation or burns. Consumers should remove the bands from children and return them for a free replacement.

    Product
    Step-iT Activity Wristbands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V610000·2016-08-22

    Zero Motorcycles Recalls 2015 Models Due to ABS Failure Risk

    Zero Motorcycles is recalling 96 model year 2015 SR, S, DS, and FX motorcycles because a faulty DC-DC converter may cause the anti-lock brake system and lights to stop working.

    Product
    ZERO — ZERO SR, S, DS, FX
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2016.