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

101–200 of 815

  • HighFDA (Devices)·Z-0948-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.

    Product
    Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1303-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0717-2020·2020-02-26

    Forest View Bakery Cheesecake Recalled for Undeclared Allergens

    Forest View Bakery is recalling cheesecakes with poppy seeds due to undeclared milk, almond, and wheat allergens.

    Product
    Forest View Bakery Cheesecake with Poppy seeds in 18oz plastic clam shell UPC 745454333860
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1271-2020·2020-02-26

    Philips HeartStart FRx AED Recalled for Quality Standards Violation

    Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.

    Product
    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0943-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling eight Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate acc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1141-2020·2020-02-26

    Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues

    Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1276-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2020·2020-02-26

    Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Collision Control Override Risk

    Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V113000·2020-02-26

    Thomas Built Buses Saf-T-Liner C2 Recall for Exterior Light Failure

    Daimler Trucks North America is recalling 2017-2020 Thomas Built Buses Saf-T-Liner C2 school buses because the exterior warning lights and stop sign may fail, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2020·2020-02-26

    Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0727-2020·2020-02-26

    CSM Bakery Products Recalls Fudge Icing Due to Plastic Polymer Contamination

    CSM Bakery Products is recalling 18 lb. pails of Ready Ice Fudge Icing because pieces of plastic polymer were introduced into the sugar system.

    Product
    18 lb. pail READY ICE FUDGE ICING, MDM # 10202894, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1336-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures for Internal Testing Failures

    Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0734-2020·2020-02-26

    Pepper Source Recalls Smoky Honey BBQ Sauce for Packing Material

    Pepper Source, Ltd. is recalling 36,233 pounds of Smoky Honey BBQ Sauce because it may contain pieces of food grade packing material.

    Product
    PS# 79770 Smoky Honey BBQ Sauce packed in 275 gallons totes
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1313-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling specific dental drills because a packaging defect may compromise their sterility during shelf life.

    Product
    Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1335-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures Due to Testing Failures

    Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0733-2020·2020-02-26

    Pepper Source Bourbon BBQ Sauce Recalled for Packing Material

    Pepper Source, Ltd. is recalling Bourbon Flavored BBQ Sauce because it may contain pieces of food grade packing material.

    Product
    Bourbon Flavored BBQ Sauce (12.8 oz Pack) 45 Packs/Case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1321-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 11 units of Implant Retrieval Instrument Tri Channel 6.0 22 mm because a packaging sealing issue may compromise sterility.

    Product
    Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1256-2020·2020-02-26

    Edan iT20 Telemetry Transmitter Recalled for Uncleared Function

    Edan Diagnostics is recalling 7 iT20 telemetry transmitters because they include a function not cleared by the U.S. FDA.

    Product
    EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2020·2020-02-26

    Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns

    Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1263-2020·2020-02-26

    Abbott i-STAT CG4+ Cartridges Recalled for Lack of FDA Clearance

    Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they are not FDA cleared and lack CLIA waived status.

    Product
    i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1247-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 1,760 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION KIT JH-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 526 Implant Retrieval Instruments because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0731-2020·2020-02-26

    CSM Bakery Products Recalls Cinnabon Cream Cheese Frosting Due to Plastic Contamination

    CSM Bakery Products is recalling Cinnabon Cream Cheese Frosting because pieces of plastic polymer were introduced into the sugar system.

    Product
    22.5 lb. cases of 24 15 oz pouches CINNABON CREAM CHEESE FROSTING, MDM # 10236082, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0735-2020·2020-02-26

    Pepper Source Recalls Mississippi Mash BBQ Sauce for Packing Material

    Pepper Source, Ltd. is recalling specific lots of Mississippi Mash BBQ Sauce because the product may contain pieces of food grade packing material.

    Product
    PS# 86293 Mississippi Mash BBQ Sauce 30 Packs/ 20.2 oz. Net WT 37.88 each Carton and PS# 86295 Mississippi Mash BBQ Sauce (20.2 oz. packs) 30 Packs/Case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1267-2020·2020-02-26

    Pentax Video Colonoscope Recalled for Lack of FDA Approval

    Pentax of America Inc is recalling specific Pentax Video Colonoscopes because they were distributed in the USA without an approved 510K.

    Product
    Pentax Video Colonoscope Model: EC34-i10L
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1270-2020·2020-02-26

    Teleflex Medical Recalls Disposable Aortic Punches Due to Packaging Compromise

    Teleflex Medical is recalling 587,066 units of Disposable Aortic Punches because packaging may be compromised, potentially affecting device sterility.

    Product
    Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1312-2020·2020-02-26

    Nobel Biocare Dental Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling 59 dental drills because a packaging defect may compromise sterility. The devices are distributed worldwide.

    Product
    Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1285-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2020·2020-02-26

    Polysorb Suture Recalled for Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Sterility Barrier Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1334-2020·2020-02-26

    Ethicon Recalls Three Stratafix Suture Units for Internal Testing Failures

    Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.

    Product
    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1302-2020·2020-02-26

    Nobel Biocare Recalls Guided Start Drills Due to Sterility Concerns

    Nobel Biocare is recalling Guided Start Drills because a packaging sealing issue may compromise the sterility of the devices during their shelf life.

    Product
    Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1262-2020·2020-02-26

    Abbott i-STAT CHEM8+ Cartridges Recalled for Lack of FDA Clearance

    Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.

    Product
    i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematoc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2020·2020-02-26

    Polysorb Suture Recalled for Potential Packaging Integrity Issues

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1250-2020·2020-02-26

    Arrow Spinal Anesthesia Set Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 90 units of Arrow SPINAL ANESTHESIA SET ASA-25090-S because the product lidstock contains the incorrect expiration date.

    Product
    Arrow SPINAL ANESTHESIA SET ASA-25090-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0770-2020·2020-02-26

    Suja Organic Ginger Bliss Smoothie Recalled for Unapproved Herbicide

    Suja Life LLC is recalling 9,005 bottles of Organic Ginger Bliss Fruit + Veggie Smoothie because raw flax material contained an unapproved herbicide.

    Product
    Suja Organic Ginger Bliss Fruit + Veggie Smoothie, 12 oz. UPC: 81861702236
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0853-2020·2020-02-26

    AuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity

    AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection due to elevated levels of Benzaldehyde impurity found in investigative samples.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0726-2020·2020-02-26

    CSM Bakery Products Recalls Pink Decorating Buttercreme Frosting Due to Plastic Contamination

    CSM Bakery Products is recalling 14 lb. pails of Pink Decorating Buttercreme Frosting because pieces of plastic polymer were introduced into the sugar system.

    Product
    14 lb. pail PINK DECORATING BUTTERCREME FROSTING, MDM # 10202860, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2020·2020-02-26

    Siemens ADVIA Chemistry Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.

    Product
    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.

    Product
    Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2020·2020-02-26

    Arrow PSI Kit Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 410 units of Arrow PSI Kits due to incorrect expiration dates on the product lidstock.

    Product
    Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1261-2020·2020-02-26

    Siemens Recalls Atellica CH High Sensitivity C-Reactive Protein Calibrator

    Siemens Healthcare Diagnostics is recalling Atellica CH High Sensitivity C-Reactive Protein Calibrators for in vitro diagnostic use.

    Product
    Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2020·2020-02-26

    Ormco/Sybronendo Recalls SnapLink Brackets Due to Slide Door Failure

    Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.

    Product
    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1324-2020·2020-02-26

    Nobel Biocare Recalls Abutment Screw Retrieval Kits Due to Sterility Concerns

    Nobel Biocare is recalling 7 units of Abutment Screw Retrieval Kits because a packaging sealing issue may compromise the sterility of the included medical devices.

    Product
    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2020·2020-02-26

    Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 160 units of the Arrow Epidural Catheterization Kit (YC-02220) because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION KIT YC-02220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1325-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1323-2020·2020-02-26

    Nobel Biocare Recalls Implant Retrieval Kits Due to Sterility Concerns

    Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their shelf-life.

    Product
    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0848-2020·2020-02-26

    American Health Packaging Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

    American Health Packaging is recalling Desmopressin Acetate Tablets because the product bottles may be missing desiccant.

    Product
    Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 2,470 implant retrieval instruments because a packaging defect may compromise sterility. The devices are distributed worldwide.

    Product
    Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1330-2020·2020-02-26

    Mindray DP-30 Ultrasound Systems Recalled for Incorrect Needle-Guide Display

    Mindray is recalling 53 DP-30 ultrasound systems and 18 USB drives because the devices display an incorrect needle-guide bracket when used with a specific transducer.

    Product
    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small org
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0721-2020·2020-02-26

    CSM Bakery Recalls Frozen Cookie Dough Due to Plastic Contamination

    CSM Bakery Products is recalling frozen chocolate chip cookie dough because pieces of plastic polymer were introduced into the sugar system.

    Product
    30 lb. cases of 480 1.0 oz frozen chocolate chip with mini colored candy pieces cookie dough, MDM # 10194626, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2020·2020-02-26

    Pentax Video Colonoscope Recalled for Lack of FDA Approval

    Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).

    Product
    Pentax Video Colonoscope Model: EC38-i10L
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1287-2020·2020-02-26

    FDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2020·2020-02-26

    Arrow International Recalls Tuohy Needles With Incorrect Expiration Dates

    Arrow International Inc is recalling 2,126 units of STIM and INSL CPNB Tuohy needles because the product lidstock contains the incorrect expiration date.

    Product
    (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0771-2020·2020-02-26

    Suja Organic Mango Mojito Smoothie Recalled for Unapproved Herbicide

    Suja Life LLC is recalling 6,817 bottles of Organic Mango Mojito Fruit + Veggie Smoothie due to the presence of an unapproved herbicide in raw flax material.

    Product
    Suja Organic Mango Mojito Fruit + Veggie Smoothie, 12 oz. UPC: 81861702240
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1243-2020·2020-02-26

    Arrow Central Venous Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 140 units of Central Venous Catheterization Kits because the product lidstock contains the incorrect expiration date.

    Product
    Arrow Central Venous Catheterization Kit ASK-04200-UPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0769-2020·2020-02-26

    Suja Organic Berry Zest Smoothie Recalled for Unapproved Herbicide

    Suja Life LLC is recalling 7,660 bottles of Organic Berry Zest Fruit + Veggie Smoothie due to an unapproved herbicide found in raw flax material.

    Product
    Suja Organic Berry Zest Fruit + Veggie Smoothie, 12 oz. UPC: 81861702234
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1234-2020·2020-02-26

    Medicrea Universal Counter Torque Recalled Due to Incompatibility with Nut Driver

    Medicrea International is recalling 3 units of Universal Counter Torque for the Pass TULIP Spinal System because they are incompatible with the T30 nut driver.

    Product
    Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1300-2020·2020-02-26

    Biosyn Monofilament Absorbable Suture Recalled for Packaging Integrity Issues

    FDA is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23 due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1277-2020·2020-02-26

    Polysorb Suture Recall Due to Packaging Integrity Issues

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact sterility.

    Product
    Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1251-2020·2020-02-26

    Arrow Epidural Catheterization Component Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 540 units of the Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 870 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.

    Product
    Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2020·2020-02-26

    American Health Packaging Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

    American Health Packaging is recalling Desmopressin Acetate Tablets because product bottles may be missing desiccant.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0722-2020·2020-02-26

    CSM Bakery Products Recalls Donut Glaze Due to Plastic Polymer Contamination

    CSM Bakery Products is recalling 40 lb. pails of GLAZE 'N SHINE donut glaze because pieces of plastic polymer were introduced into the sugar system.

    Product
    40 lb. pail GLAZE 'N SHINE donut glaze, MDM # 10198587, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1258-2020·2020-02-26

    Ormco SnapLink Brackets Recalled for Slide Door Failure

    Ormco/Sybronendo is recalling SnapLink brackets because lower buccal tube slide doors may not stay closed, potentially causing tooth rotation or treatment delays.

    Product
    SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1304-2020·2020-02-26

    Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns

    Nobel Biocare is recalling 8 Dense Bone Drills because a packaging defect may compromise sterility during shelf life.

    Product
    Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1289-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1327-2020·2020-02-26

    Binding Site OPTILITE IgM Kit Recalled for Potential Calibration Issues

    The Binding Site Group is recalling OPTILITE IgM Kits due to potential calibration difficulties that may cause false patient results and testing delays.

    Product
    OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1306-2020·2020-02-26

    Nobel Biocare Tapered Drills Recalled Due to Sterility Concerns

    Nobel Biocare is recalling specific tapered dental drills because a packaging defect may compromise their sterility during shelf life.

    Product
    Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0768-2020·2020-02-26

    Don Lee Farms Chipotle Black Bean Burgers Recalled for Unapproved Herbicide

    Don Lee Farms is recalling specific lots of Chipotle Black Bean and Black Burgers because an ingredient was grown using an unapproved herbicide.

    Product
    Don Lee Farms Chipotle Black Bean Burger 12 pack/3Lbs. cartons UPC 087427438135, Item 1372617 Don Lee Farms Chipotle Black Burger 10 pack/2.5 lb. cartons UPC 087427430757/Item 997176SF
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1249-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 1,360 units of the Arrow Epidural Catheterization Kit CK-02220 because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION KIT CK-02220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2020·2020-02-26

    Abbott i-STAT G3+ Cartridge Recalled for Lack of Clinical Evidence

    Abbott Point of Care is recalling i-STAT G3+ blue cartridges because it lacks sufficient clinical evidence to characterize their performance.

    Product
    i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2020·2020-02-26

    Arrow Epidural Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 1,320 units of the Arrow Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL CATHETERIZATION KIT AM-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1244-2020·2020-02-26

    Arrow Epidural Needle Component Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 1,839 units of Arrow Epidural Needle Component AN-05505 because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL NEEDLE COMPONENT AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1255-2020·2020-02-26

    Arrow PICC Kit Recalled for Incorrect Expiration Date on Lidstock

    Arrow International is recalling specific lots of PICC kits because the lidstock displays the wrong expiration date.

    Product
    Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1239-2020·2020-02-26

    Arrow FlexTip Plus Catheterization Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 1,150 units of FlexTip Plus Combined Spinal Epidural Catheterization Kits because the product lidstock contains the incorrect expiration date.

    Product
    Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1252-2020·2020-02-26

    Arrow Epidural Needle Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling 180 units of the Arrow EPIDURAL NEEDLE KIT SL-05500 because the product lidstock contains the incorrect expiration date.

    Product
    Arrow EPIDURAL NEEDLE KIT SL-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0844-2020·2020-02-26

    Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure

    The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1241-2020·2020-02-26

    Arrow StimuCath Continuous Nerve Block Kit Recalled for Incorrect Expiration Date

    Arrow International Inc is recalling 155 units of the StimuCath Continuous Nerve Block Kit because the product lidstock contains an incorrect expiration date.

    Product
    Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1259-2020·2020-02-26

    Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error

    Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.

    Product
    HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1326-2020·2020-02-26

    Theralase Inc. Recalls TLC-2000 Therapeutic Medical Laser Systems

    Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.

    Product
    TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0851-2020·2020-02-26

    Teva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling

    Teva Pharmaceuticals is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.

    Product
    Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
    Category
    Drug
    Distribution
    Distributed nationwide

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