The Recall Desk

Archive

February 2020 recalls

815 recalls were announced in February 2020.

What the numbers show

Critical
88
Severe
191
High
354
Moderate
163
Low
19

Of the 815 recalls this month scored against our rubric, 11% are Critical, 23% are Severe.

Which agencies issued them

601–700 of 815

  • HighFDA (Devices)·Z-1048-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Surgical Trays Due to Seal Defects

    Centurion Medical Products is recalling various sterile surgical trays and packs because incomplete seals may compromise sterility.

    Product
    Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Pathology Containers Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific sterile pathology containers and kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2020·2020-02-12

    Centurion Irrigation Kit Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 270 irrigation kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Biopsy and Arthrogram Trays

    Centurion Medical Products is recalling specific sterile biopsy and arthrogram trays due to incomplete seals that may compromise sterility.

    Product
    Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF SPEC0265A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2020·2020-02-12

    Dexcom G5 Mobile Receiver Recalled for Software Glitches

    Dexcom Inc is recalling 112,415 G5 Mobile Receivers due to software issues that may prevent patients from receiving glucose values or alerts.

    Product
    Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in peo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 Fabric Reinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2020·2020-02-12

    Cook Inc. Recalls Fixed Core Straight Safety Wire Guide

    Cook Inc. is recalling 15 units of Fixed Core Straight Safety Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients.

    Product
    Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific sterile pitcher kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2020·2020-02-12

    Cook Inc. Recalls Wire Guide Due to Incorrect Loading Risk

    Cook Inc. is recalling 13,388 Wire Guide units because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Wire Guide, Guidewire, Global Product Number G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2020·2020-02-12

    Centurion Chest Tube Trays Recalled for Incomplete Package Seals

    Centurion Medical Products is recalling 448 chest tube trays because incomplete seals may compromise sterility.

    Product
    Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE INSE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 ROYALSILK SURGGOWN BNS XL units worldwide due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2020·2020-02-12

    B. Braun Recalls Safeline Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 19,500 Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.

    Product
    Safeline Y-Type Blood Set, Catalog Number V2500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2020·2020-02-12

    Cook Inc. Recalls Urethral Dilation Balloon Catheters Due to Wire Guide Defect

    Cook Inc. is recalling 13,388 Urethral Dilation Balloon Catheters because the wire guide may be incorrectly loaded, potentially introducing a stiff tip into the patient.

    Product
    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2020·2020-02-12

    Centurion Circumcision Tray Kits Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling specific Circumcision Tray Kits because incomplete seals on the sterile packaging may compromise sterility.

    Product
    Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects

    Centurion Medical Products is recalling various sterile dressing change kits and trays because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2020·2020-02-12

    Cocoon Convective Warming System Recalled for Thermal Damage Risk

    Care Essentials is recalling 251 Cocoon Convective Warming Systems due to a potential for thermal damage near the power cord connector and Power Entry Module.

    Product
    Cocoon Convective Warming System, Product Code: CWS5000 (110V).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Trays Due to Seal Defects

    Centurion Medical Products Corporation is recalling various sterile dressing change trays and procedure kits because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2020·2020-02-12

    Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Defect

    Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

    Product
    Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2020·2020-02-12

    Centurion Driveline System Kit Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 100 units of the Driveline System Kit because incomplete seals may compromise sterility.

    Product
    Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2020·2020-02-12

    Centurion Medical Products Recalls Biopsy Trays Due to Incomplete Seals

    Centurion Medical Products is recalling specific biopsy trays because incomplete sterile package seals may compromise sterility.

    Product
    Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2020·2020-02-12

    Centurion Incision and Drainage Trays Recalled for Incomplete Seals

    Centurion Medical Products is recalling specific Incision and Drainage Trays because incomplete seals may compromise sterility.

    Product
    Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2020·2020-02-12

    Cardinal Health Recalls AAMI 3 Surgical Gowns Due to Contamination

    Cardinal Health is recalling AAMI 3 non-radiation-protective surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2020·2020-02-12

    Cook Inc. Recalls Heavy Duty PTFE Wire Guides Due to Loading Error

    Cook Inc. is recalling 146 Heavy Duty PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2020·2020-02-12

    Lumitex Giraffe Blue Spot PT Lite Phototherapy Systems Recalled for Low Light Output

    Lumitex is recalling Giraffe Blue Spot PT Lite Phototherapy Systems because some units may have light output below the recommended minimum.

    Product
    Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M123849
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0997-2020·2020-02-12

    Roche Recalls Accu-Chek Aviva Plus Blood Glucose Test Strips

    Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.

    Product
    Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2020·2020-02-12

    Roche Accu-Chek Aviva Test Strips Recalled for Dosing Issues

    Roche Diabetes Care is recalling Accu-Chek Aviva test strips because they may fail to dose, potentially delaying blood glucose results and treatment decisions.

    Product
    ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2020·2020-02-12

    B. Braun Recalls Y-Type Blood Sets Due to Leakage Risk

    B. Braun Medical is recalling 1,050 Y-Type Blood Sets because they may leak at the joint between the blood filters and tubing.

    Product
    Y-Type Blood Set, Catalog Number 490293
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.

    Product
    Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0933-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Food)·F-0631-2020·2020-02-12

    Meijer Joint Health Glucosamine Recalled for Missing Shellfish Allergen Labeling

    Merical, LLC is recalling Meijer Joint Health Glucosamine tablets because the label fails to identify crustacean shellfish as an ingredient.

    Product
    Meijer Joint Health Triple Strength Formula Glucosamine Hydrochloride 1500 mg; Helps Overall Joint Physical Function; Unit Size - 40 count and 80 count - 2 tablets per day. Item Numbers: MEIJER7754 (40 count) & MEIJER7755 (80 count) UPC Code: 713733563024 & 713733563031 resp
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1075-2020·2020-02-12

    Centurion Suture Tray Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling Suture Trays because incomplete seals on the sterile package may compromise sterility.

    Product
    Centurion-Suture Tray DYNDR1210A SUTURING TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2020·2020-02-12

    Centurion Blood Culture Collection Kit Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling blood culture collection kits due to incomplete seals that may compromise sterility.

    Product
    Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific lots of AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2020·2020-02-12

    Centurion Medical Products Recalls Surgical Trays Due to Incomplete Seals

    Centurion Medical Products is recalling various surgical trays and kits because incomplete seals on the sterile packages may compromise sterility.

    Product
    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0593-2020·2020-02-12

    Munk Pack Almond Butter Keto Granola Bar Recalled for Undeclared Milk

    Munk Pack Inc. is recalling Almond Butter Cocoa Chip Keto Granola Bars because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Munk Pack Almond Butter Cocoa Chip Keto Granola Bar, 4 pack, 128 g
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1089-2020·2020-02-12

    Centurion Nasal Speculums Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 1,820 sterile nasal speculums due to incomplete package seals that may compromise sterility.

    Product
    Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2020·2020-02-12

    Cardinal Health Genius 3 Tympanic Thermometer Recalled for Accuracy Drift

    Cardinal Health is recalling Genius 3 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.

    Product
    Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2020·2020-02-12

    Pacific Medical Ultrasound Transducers Recalled for Missing Clearances

    Pacific Medical Group Inc. is recalling 225 ultrasound transducers distributed before receiving required FDA and international clearances.

    Product
    Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0916-2020·2020-02-12

    King Vision Video Adapter Recalled for Reversed Image Display

    King Systems Corp. is recalling King Vision Video Adapters because the display shows a reversed image, causing left and right actions to be inverted.

    Product
    King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2020·2020-02-12

    Microbiologics Recalls Vaginal Verification Panel Due to Contamination

    Microbiologics Inc is recalling 9 units of the Vaginal Verification Panel Lot 8208-11 because Pool 2 contains the wrong organism, Candida krusei.

    Product
    Vaginal Verification Panel Ref 8208 Lot 8208-11
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0830-2020·2020-02-12

    Teva Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

    Teva Pharmaceuticals USA is recalling Desmopressin Acetate Tablets because bottles may be missing desiccant, a GMP deviation.

    Product
    Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1102-2020·2020-02-12

    Wright Medical Recalls EVOLVE Modular Radial Heads Due to Sizing Errors

    Wright Medical Technology is recalling two lots of EVOLVE Modular Radial Heads because the product size in the package may be incorrect. Both labels and laser markings are wrong.

    Product
    WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0981-2020·2020-02-12

    Pacific Medical Ultrasound Transducers Recalled for Lack of FDA Clearance

    Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound Transducers because they were distributed before receiving required FDA 510(k) and international clearances.

    Product
    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0979-2020·2020-02-12

    Pacific Medical fetal transducers recalled for lack of regulatory clearance

    Pacific Medical Group is recalling 772 fetal transducers distributed in the U.S. and abroad before receiving required FDA 510(k) and international clearances.

    Product
    Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0931-2020·2020-02-12

    PediaLift Access Device Recalled for Labeling Compliance Issues

    PediaLift LLC is recalling 11 PediaLift Access Devices because the firm could not obtain a satisfactory Certificate of Conformance from the original vendor regarding labeling requirements.

    Product
    PediaLift Access Device, Device Identifier: B751PDLFT0
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0832-2020·2020-02-12

    Graviti Pharmaceuticals Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Graviti Pharmaceuticals is recalling 29,056 bottles of 10 mg Atorvastatin Calcium Tablets because a 20 mg tablet was found in a bottle labeled for 10 mg tablets.

    Product
    Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2020·2020-02-12

    Ascend Recalls Minocycline Hydrochloride Tablets for Dissolution Failures

    Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets due to low dissolution test results.

    Product
    MINOCYCLINE HYDROCHLORIDE — MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0831-2020·2020-02-12

    Teva Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

    Teva Pharmaceuticals USA is recalling Desmopressin Acetate Tablets because bottles may be missing desiccant, a GMP deviation.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2020·2020-02-12

    Macleods Pharma Recalls Subpotent Pioglitazone and Metformin Tablets

    Macleods Pharma USA is recalling two lots of Pioglitazone and Metformin Hydrochloride tablets because they tested below the required potency levels.

    Product
    PIOGLITAZONE AND METFORMIN HYDROCHLORIDE — PIOGLITAZONE AND METFORMIN HYDROCHLORIDE (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2020·2020-02-12

    Implant Direct Sybron Recalls Legacy 3 Dental Implants Due to Incorrect Packaging

    Implant Direct Sybron is recalling 72 Legacy 3 dental implants because some packages contain incorrect implants, which could lead to surgery rescheduling.

    Product
    Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2020·2020-02-12

    Pacific Medical Fetal Transducers Recalled for Missing Regulatory Clearances

    Pacific Medical Group Inc. is recalling 261 fetal transducers distributed in the U.S. and abroad before receiving required FDA and international clearances.

    Product
    Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-1101-2020·2020-02-12

    Wright Medical Recalls EVOLVE Modular Radial Head Due to Sizing Errors

    Wright Medical Technology is recalling 39 EVOLVE Modular Radial Heads because the product size inside the package does not match the label or laser marking.

    Product
    WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0990-2020·2020-02-12

    Cardinal Health Recalls Genius 2 Tympanic Thermometers for Accuracy Drift

    Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings stay within the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0992-2020·2020-02-12

    Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift

    Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0983-2020·2020-02-12

    Pacific Medical Ultrasound Transducers Recalled for Missing Clearances

    Pacific Medical Group Inc. is recalling 678 fetal ultrasound transducers because they were distributed before receiving required FDA 510(k) and international clearances.

    Product
    Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0982-2020·2020-02-12

    Pacific Medical Nautilus Ultrasound Recalled for Missing Clearances

    Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound units because fetal transducers were distributed before receiving required FDA and international clearances.

    Product
    Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0994-2020·2020-02-12

    Cardinal Health Genius 2 Tympanic Thermometer Recall for Accuracy Drift

    Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.

    Product
    Genius 2 Tympanic Thermometer Private Label Item Code: 3069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0589-2020·2020-02-12

    Cargill Recalls Granulated Cane Sugar Due to Foreign Material

    Cargill is recalling Marigold Granulated Cane Sugar because foreign material was found in the product. The affected product was shipped to Georgia.

    Product
    Marigold, INC. Granulated Cane Sugar Net Weight: 2000#
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1105-2020·2020-02-12

    Intuitive Surgical Recalls Da Vinci Xi EndoWrist Monopolar Curved Scissors

    Intuitive Surgical is recalling 286 Da Vinci Xi EndoWrist Monopolar Curved Scissors because they are not recognized by the integrated electrosurgical unit, preventing the activation of monopolar energy.

    Product
    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
    Category
    Medical Device
    Distribution
    37 states
  • LowFDA (Drugs)·D-0829-2020·2020-02-12

    Unichem Recalls Clonidine Hydrochloride Tablets Due to Benzophenone Migration

    Unichem Pharmaceuticals is recalling Clonidine Hydrochloride tablets due to potential benzophenone migration from container labels. This is a precautionary measure.

    Product
    CLONIDINE HYDROCHLORIDE — CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1100-2020·2020-02-12

    Randox Liquid Clinical Chemistry Control Recalled for Transcription Error

    Randox Laboratories is recalling Liquid Clinical Chemistry Control lot 1021 UE due to a transcription error in the Lipase value.

    Product
    Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0924-2020·2020-02-12

    Neodent Tapered Guided Surgery Drill Recalled for Incorrect Laser Engraving

    Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two Neodent Tapered Guided Surgery Drills because the laser engraving incorrectly identifies the model.

    Product
    Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·20V074000·2020-02-11

    Blue Bird Recalls 2018-2019 School Buses Due to Wire Harness Defect

    Blue Bird is recalling 2018-2019 Vision and All American school buses because a wire harness connector may unplug, causing sudden loss of drive power and power steering.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V071000·2020-02-10

    Yamaha Recalls 2019 YZF-R3 Motorcycles Due to Front Brake Hose Chafing

    Yamaha is recalling 1,561 2019 YZF-R3 motorcycles because the front brake hose may chafe against the horn wire, potentially causing a brake fluid leak and reduced braking ability.

    Product
    YAMAHA — YAMAHA YZFR3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V070000·2020-02-10

    Forest River Recalls 2020 Cedar Creek Trailers Due to Fire Risk

    Forest River is recalling 2020 Cedar Creek trailers because the stove may be too close to the window valance, posing a fire hazard.

    Product
    FOREST RIVER — FOREST RIVER CEDAR CREEK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2020·2020-02-08

    Family Traditions Recalls Beef Sticks for Undeclared Milk Allergen

    Family Traditions Meat Company is recalling ready-to-eat beef sticks because they contain milk, an undeclared allergen. No illnesses have been reported.

    Product
    Family Traditions Meat Company, Inc. — Family Traditions Meat Company Recalls Ready-to-Eat Meat Stick Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·20E005000·2020-02-07

    Ferrara Recalls Pelican Flashlights Due to Battery Explosion Risk

    Ferrara Fire Apparatus is recalling Pelican Flashlights models 9410 and 9415 supplied with emergency vehicles because the battery pack may explode while charging.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V068000·2020-02-07

    Mercedes-Benz Recalls 2020 Models for Emergency Call System Location Error

    Mercedes-Benz is recalling 239 vehicles from 2020 because a damaged electrical circuit in the eCall module may relay inaccurate location data, potentially delaying emergency responders.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, E 450, E 350, AMG GT63S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V066000·2020-02-06

    Honda Recalls 2018-2020 Odyssey Vehicles for Electrical Fire Risk

    Honda is recalling 2018-2020 Odyssey vehicles because a pinched wire harness in the third row seat area could cause an electrical short and fire.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E004000·2020-02-06

    Freedman Seat Belt Retractor Recall for Improper Occupant Securing

    Freedman Seating Company is recalling certain seat assemblies because the seat belt retractor block out zone may not be set correctly, potentially failing to secure occupants.

    Product
    SEAT BELTS:FRONT:RETRACTOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20071·2020-02-06

    Infantino Recalls Infant Carriers Due to Buckle Breakage and Fall Hazard

    Infantino is recalling about 14,000 infant carriers because the buckles can break, posing a fall hazard. No injuries have been reported.

    Product
    Go Forward 4-in-1 Evolved Ergonomic, Flip Front2back and Up Close Newborn infant carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V064000·2020-02-06

    Toyota and Lexus Vehicles Recalled Due to Engine Coolant Leak Risk

    Toyota and Lexus vehicles with 2020 model years are recalled because porosity in engine castings may cause coolant leaks, potentially leading to engine overheating, stalling, and fire risk.

    Product
    TOYOTA — TOYOTA, LEXUS RAV4, RAV4 HYBRID, CAMRY HYBRID, CAMRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20069·2020-02-06

    Star Water Systems Recalls Sump Pumps Due to Fire Hazard

    Star Water Systems is recalling about 33,000 sump pumps sold under Utilitech, Do It, and Star Water Systems brands because they can overheat and cause fires.

    Product
    Sump Pumps sold under Utilitech, Do It and Star Water Systems brands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20070·2020-02-06

    DR Walk-Behind Leaf Blowers Recalled for Projectile Hazard

    Country Home Products is recalling specific DR walk-behind leaf blowers because internal blades can break off and discharge, posing a projectile hazard.

    Product
    Leaf blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0640-2020·2020-02-05

    Five Star Food Inc Recalls Sesame Tahini Jars Due to Salmonella

    Five Star Food Inc is recalling Excellent tahina jars because product samples tested positive for Salmonella.

    Product
    Excellent tahina (sesame tahini) 800 g and 400 g jars, UPC 6214002717420 and 6214002717413
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0566-2020·2020-02-05

    Dianne's Fine Desserts Recalls Frozen Brownies Due to Undeclared Peanuts

    Dianne's Fine Desserts is recalling frozen Sienna Chocolate Turtle Brownies because they contain undeclared peanuts. The product was distributed in Michigan, Illinois, and Indiana.

    Product
    Sienna Chocolate Turtle Brownie (frozen); 108 OZ (6.75 LB) Uncut, 4 trays per case; UPC: 93901541857 SSC:10093901541854
    Category
    Food
    Distribution
    3 states

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