The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
113
High
287
Moderate
299
Low
51

Of the 766 recalls this month scored against our rubric, 2% are Critical, 15% are Severe.

Which agencies issued them

201–300 of 766

  • HighFDA (Food)·F-0917-2018·2018-03-21

    Kodiak Cakes Energy Waffles Recalled for Undeclared Milk Allergen

    Kodiak Cakes is recalling Energy Waffles, Blueberry Chia, because the product contains whey but fails to declare the major food allergen milk on the label.

    Product
    Kodiak Cakes, Energy Waffles, Blueberry Chia, Net Wt 10.72 Oz (304 g), Kodiak Cakes, Park City, UT. Packaging configuration: 8-ct chipboard carton (selling unit); 8 cartons per shipping case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0929-2018·2018-03-21

    Plant Devas Blue Face Care Kit Recalled for Microbial Contamination

    Plant Devas Inc. is recalling the Blue Face Care Kit because FDA testing found excessive and virulent microorganisms in the product.

    Product
    Blue Face Care Kit; Each kit contains: Blue Lavender Cleansing Milk 1 fl oz bottle Lavender Facial Tonic HydroSoul 1 fl oz bottle Rosehip Treatment Facial Serum - BLUE 0.13 fl oz vial Blue Chamomile Day Moisturizer 0.17 fl oz jar Green Tea Clay 0.1 oz jar evanh
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0919-2018·2018-03-21

    Maple Minis Donut Bites Recalled for Undeclared Soy Lecithin

    Paige Common is recalling 46 packages of Maple Minis-Gluten Free Donut Bites sold in Oregon due to undeclared soy lecithin.

    Product
    Maple Minis-Gluten Free, Donut Bites. Packaged in clam shell with label on top. 5 oz package. UPC 8 81314 32681 5. The product is read in parts: "***maple minis***5oz***Eatin' Alive***PLANT BASED NOSH***Keep Refrigerated***INGREDIENTS: GF OATS, COCONUT, MAPLE SYRUP, COCONUT OI
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0993-2018·2018-03-21

    Zimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty

    Zimmer Biomet is recalling 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.

    Product
    JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1007-2018·2018-03-21

    Medtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters

    Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.

    Product
    MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1065-2018·2018-03-21

    Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation

    Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.

    Product
    ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraopera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2018·2018-03-21

    Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues

    Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18E016000·2018-03-21

    BMW Recalls Accessory Motorcycle Windscreens Due to Visibility Issues

    BMW is recalling specific accessory windscreens for various motorcycle models because extra tinting may reduce rider visibility, increasing crash risk.

    Product
    BMW — BMW S1000 R, S1000 XR, R1200 R, F700 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0934-2018·2018-03-21

    Blue Moose Recalls Nut-Free Basil Pesto Due to Undeclared Tree Nuts

    Blue Moose of Boulder, LLC is recalling 504 units of All-Natural Ciolo Nut-Free Basil Pesto because the product contains undeclared tree nuts.

    Product
    All-Natural Ciolo Nut-Free Basil Pesto, 7 oz., plastic container, Item #: 30019.18
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0918-2018·2018-03-21

    Almond Love Bar Vegan Chocolate Bars Recalled for Undeclared Soy

    Paige Common is recalling Almond Love Bar vegan chocolate bars due to undeclared soy lecithin. The product was distributed in Oregon.

    Product
    Almond Love Bar - Vegan Chocolate Bar, wrapped in plastic wrap with label on top. 2.5 oz bar. UPC 0 91037 32678 2 The product is read in parts: "***almond love bar***2.5oz***Eatin' Alive***PLANT BASED NOSH***Keep Refrigerated***Ingredients: Crust (Almond, Coconut Oil, Cacao,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1072-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.

    Product
    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0922-2018·2018-03-21

    Seviroli Cannoli Shells Recalled for Undeclared Soy Lecithin

    Ariola Foods is recalling Seviroli brand Cannoli Shells in New York due to undeclared soy lecithin.

    Product
    Seviroli brand Cannoli Shells. Large Plain 36 ct., and Small Plain 72 ct.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0989-2018·2018-03-21

    Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1027-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2018·2018-03-21

    Zimmer Biomet Recalls Natural-Knee II Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee II knee implants because LDPE packaging may leave residue on the polished implant surfaces.

    Product
    NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP FEM LT SZ3 NATURAL-KNE The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2018·2018-03-21

    Zimmer Biomet Recalls Versus 8 Inch Beaded Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versus 8 Inch Beaded hip implants because LDPE packaging may leave residue on the polished surface.

    Product
    VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1052-2018·2018-03-21

    Zimmer Biomet Recalls Patello-Femoral Joint Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 patello-femoral joint implants because LDPE bag packaging may leave residue on the highly polished implant surfaces.

    Product
    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1062-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.

    Product
    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1022-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0945-2018·2018-03-21

    3M Recalls Futuro and ACE Ankle Supports Due to Missing Latex Warning

    3M is recalling Futuro and ACE ankle supports because they contain natural latex rubber but lack the required caution statement.

    Product
    FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1055-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.

    Product
    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee Flex System femoral components because LDPE packaging may leave residue on the polished implant surface.

    Product
    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1045-2018·2018-03-21

    Zimmer Biomet Recalls NEXGEN LPS-FLEX Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling NEXGEN LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1058-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.

    Product
    CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1036-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific knee implant models because LDPE packaging may leave residue on the polished surface.

    Product
    LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2018·2018-03-21

    Zimmer Biomet Recalls Versus Hip Stems Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versus hip stems because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1021-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1011-2018·2018-03-21

    Zimmer Biomet Recalls Mislabelled Vanguard CR Porous Femoral Knee Implants

    Zimmer Biomet is recalling eight Vanguard CR Porous Femoral knee implants because they are labeled as 62.5mm Left Femurs but contain 70mm Right Femurs.

    Product
    Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1041-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0974-2018·2018-03-21

    Stryker Recalls Collagen Meniscus Implants Due to Temperature Packaging Defect

    Stryker is recalling 155 Collagen Meniscus Implants shipped to the Netherlands without required temperature control packaging, potentially exposing them to elevated temperatures.

    Product
    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small q
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0591-2018·2018-03-21

    Oxytocin USP Powder Recalled Due to Insufficient Stability Data

    American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration dates.

    Product
    Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1034-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0973-2018·2018-03-21

    Laerdal LCSU 4 Suction Units Refused Importation for Lack of FDA Approval

    Laerdal Medical Corporation is recalling 204 LCSU 4 suction units that were refused entry into the U.S. by the FDA because they lacked necessary CDRH approvals.

    Product
    LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. High
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1047-2018·2018-03-21

    Zimmer Biomet Recalls CR-FLEX Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L CR-FLEX OPT FEM G-R This device is indicated for patients with severe knee pain and disa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.

    Product
    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1053-2018·2018-03-21

    Zimmer Biomet Recalls Patella Femoral Joint Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 patella femoral joint implants because LDPE bag packaging may leave residue on the polished surface.

    Product
    ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1043-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0592-2018·2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Reagent Due to Homogeneity Defect

    Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1051-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect

    Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1037-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿ ZUK PRC FEM SZD RMED/LLAT¿ ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLAT " These devices are indicated for patients with: - Painful and/or disabling knee joi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1059-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ D-R¿ CR-FLEX GSF PRECOAT SZ E-L¿ CR-FLEX GSF PRECOAT SZ E-R¿ CR-FLEX GSF PRECOAT SZ F-L¿ CR-FLEX GSF PRECOAT SZ F-R¿ CR-FLEX GSF PRECOAT SZ G-L¿ CR-FLEX GSK PRECOAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1064-2018·2018-03-21

    Zimmer Biomet Recalls Mislabeled Cannulated Screws Due to Labeling Error

    Zimmer Biomet is recalling six 6.5mm x 125mm x 16mm Cannulated Screws because they were mislabeled as 3.5mm x 24mm Cortical Locking screws.

    Product
    6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0601-2018·2018-03-21

    Valganciclovir Tablets Recalled Due to Temperature Exposure During Shipping

    Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.

    Product
    VALGANCICLOVIR — VALGANCICLOVIR (VALGANCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1048-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0937-2018·2018-03-21

    Randox Liquid Cardiac Control CQ5053 Recalled for Shelf-Life Labeling Error

    Randox is recalling 450 kits of Liquid Cardiac Control CQ5053 because the product does not meet its shelf-life claim, potentially causing test results to fall outside control ranges.

    Product
    Liquid Cardiac Control CQ5053
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1032-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This dev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1031-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2018·2018-03-21

    Arrow CVC Kit Recall for Missing Lot and UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1050-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.

    Product
    CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX PCT FEM E-L CR-FLEX PCT FEM E-R CR-FLEX PCT FEM F-L CR-FLEX PCT FEM F-R CR-FLEX PCT FEM G-L CR-FLEX PCT FEM G-R This device is indicated for patients with seve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1046-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surface.

    Product
    CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-L MINUS CR-FLEX OPT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0979-2018·2018-03-21

    Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching

    Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers. The size difference is visually recognizable to the user.

    Product
    Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2018·2018-03-21

    Vygon IV Start Convenience Kits Recalled for Iodine Stability Issues

    Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.

    Product
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1057-2018·2018-03-21

    Zimmer Biomet Recalls NEXGEN GSF Porous Femoral LPS Flex Implants

    Zimmer Biomet is recalling NEXGEN GSF Porous Femoral LPS Flex implants because LDPE packaging may leave residue on the polished surface.

    Product
    NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2018·2018-03-21

    Howmedica Recalls Accolade and Restoration Hip Products Due to Sealing Defect

    Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.

    Product
    Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1044-2018·2018-03-21

    Zimmer Biomet Recalls LPS-FLEX Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 LPS-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0995-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Label Information

    Arrow International is recalling 23,904 central venous catheter kits because some units may be missing stickers with lot, expiration, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1030-2018·2018-03-21

    Zimmer Biomet Recalls Knee Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling specific knee prostheses because the packaging bags may leave residue on the implant surface.

    Product
    CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1061-2018·2018-03-21

    Zimmer Biomet Recalls Natural-Knee Flex Femoral Components Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee Flex femoral components because LDPE packaging may leave residue on the polished implant surface.

    Product
    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1015-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip implants because LDPE packaging may leave residue on the polished surface.

    Product
    CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip implants because LDPE packaging may leave residue on the polished surface.

    Product
    CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL F-R LPS OPTION FEMORAL G-L LPS OPTION FEMORAL G-R LPS OPTION FEMORAL H-L This device is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0940-2018·2018-03-21

    Howmedica Recalls Accolade and Restoration Hip Products Due to Barrier Defects

    Howmedica Osteonics Corp. is recalling 255 Accolade and Restoration hip products because the inner and outer sterile barriers were not fully sealed.

    Product
    Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2018·2018-03-21

    Novel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

    Novel Laboratories is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2018·2018-03-21

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Potassium Concentration Error

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate because some units in the affected lot had a potassium concentration of 2.25 mEq/L instead of the labeled 2.0 mEq/L.

    Product
    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialy
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1038-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip and knee implants because the packaging bags may leave residue on the polished surfaces.

    Product
    LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0921-2018·2018-03-21

    Ripple Chocolate Nutritious Pea Milk Recalled for High Coliform Levels

    Ripple Foods is recalling 448 cases of 48 oz. Chocolate Nutritious Pea Milk due to high levels of coliforms and Serratia liquefaciens.

    Product
    ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Calcium than Milk 32 mg DHA Omega 3's UPC: 8 55643 00607 6 Distributed by Ripple Foods, Emeryville, CA
    Category
    Food
    Distribution
    3 states

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