The Recall Desk

Archive

June 2020 recalls

478 recalls were announced in June 2020.

What the numbers show

Critical
9
Severe
97
High
240
Moderate
118
Low
14

Of the 478 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

301–400 of 478

  • HighFDA (Devices)·Z-2196-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 4,065 Gambro Cartridge Low Weight-Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20132·2020-06-10

    Island Wear Recalls Umbrella Strollers Due to Fall and Choking Hazards

    Island Wear is recalling about 940 umbrella strollers sold in Ocean City, Md., because they violate federal safety standards, posing fall and choking risks to children.

    Product
    Umbrella strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0975-2020·2020-06-10

    Dragonfly Galanga Powder Recalled for Lead Contamination

    U.S. Tov, Inc. is recalling Dragonfly brand Galanga Powder because testing by the New York State Dept of Agriculture and Markets found it contains lead.

    Product
    Dragonfly brand Galanga Powder; Net Weight: 5 oz. (142 g) UPC: 7 21557 53337 6 Product of Thailand Distributed by U.S. Trading Company, Hayward, CA 94545-1130
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-0990-2020·2020-06-10

    Plucker's Wing Bar Sesame Wing Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling 180 bottles of Plucker's Wing Bar Sesame Wing Sauce sold in Texas and Louisiana due to potential undeclared wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Sesame 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2252-2020·2020-06-10

    FDA Recalls Multifire VersaTrack Auto Suture Hernia Stapler Due to Assembly Error

    The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may cause staples to fail to advance properly.

    Product
    Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2242-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin Antibody II assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2202-2020·2020-06-10

    Agfa DR 800 X-Ray System Recalled for Dose Calculation Error

    Agfa N.V. is recalling 13 DR 800 digital radiography systems because a software error may cause incorrect dose calculations during specific fluoroscopic exams.

    Product
    AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2020·2020-06-10

    Baxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential tubing disconnection hazard during hemodialysis treatment.

    Product
    Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out post-operatively.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2020·2020-06-10

    Hill-Rom Centrella Smart+ Bed Recall for Alert System Failure

    Hill-Rom is recalling 4,381 Centrella Smart+ Beds because the Bed Exit System may fail to send remote alerts to the nurse call system under specific conditions.

    Product
    Centrella Smart+ Bed, Catalog Number P7900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0986-2020·2020-06-10

    Plucker's Wing Sauce Recalled for Undeclared Soy and Wheat

    Zilks Foods is recalling Plucker's Wing Bar World Famous Wing Sauce Baker's Gold due to potential undeclared soy and wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Baker's Gold 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2176-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2020·2020-06-10

    Inpeco FlexLab Augomation System Recalled for Potential Sample Dilution

    Inpeco S.A. is recalling 71 FlexLab Augomation Systems because a firmware error may dilute primary sample tubes with distilled water, potentially causing discrepant patient results.

    Product
    FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0993-2020·2020-06-10

    Plucker's Wing Sauce Recalled for Undeclared Soy and Wheat

    Zilks Foods is recalling 528 bottles of Plucker's Wing Bar Vampire Killer sauce in Texas and Louisiana due to potential undeclared soy and wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Vampire Killer 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0989-2020·2020-06-10

    Plucker's Wing Sauce Recalled for Potential Undeclared Milk and Soy

    Zilks Foods is recalling Plucker's Wing Bar World Famous Wing Sauce Hallelujah 12 FL OZ. bottles due to potential undeclared milk and soy allergens.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Hallelujah 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2186-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2020·2020-06-10

    Osteomed Recalls Osteovation RMX Injectable Due to Shelf-Life Labeling Error

    Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2240-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and…
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2209-2020·2020-06-10

    Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath

    Bard Peripheral Vascular Inc is recalling 400 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.

    Product
    EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2175-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2020·2020-06-10

    Beckman Coulter Free T3 Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel…
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2197-2020·2020-06-10

    Olympus ShockPulse-SE Lithotripsy Transducers Recalled for Material Defect

    Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.

    Product
    OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2020·2020-06-10

    Inpeco Accelerator a3600 Automation System Recalled for Sample Dilution Risk

    Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.

    Product
    Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2173-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1285-2020·2020-06-10

    Teva Recalls Mixed Strength Amphetamine Salts Tablets

    Teva Pharmaceuticals USA is recalling specific bottles of mixed amphetamine salts tablets because some may contain mixed strengths.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2239-2020·2020-06-10

    Beckman Coulter Access Total T3 Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Total T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel…
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2244-2020·2020-06-10

    Philips Chest Pneumograph Recalled for Missing Latex Labeling

    Philips is recalling Chest Pneumograph accessories because the labeling does not state that the product contains natural rubber latex.

    Product
    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 417 units of Osteovation 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2020·2020-06-10

    Beckman Coulter Access GI Monitor Cancer Antigen 19-9 Recalled for Biotin Interference

    Beckman Coulter is recalling Access GI Monitor Cancer Antigen 19-9 assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC…
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2168-2020·2020-06-10

    FDA Recalls Surgical Gowns from Unregistered Facility

    American Contract Systems is recalling 2,868 surgical gown kits because they were manufactured in a facility not registered with the FDA.

    Product
    Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2248-2020·2020-06-10

    Radiometer safeCLINITUBES Blood Samplers Recalled for Insufficient Aspiration

    Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, potentially resulting in lost samples.

    Product
    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-2166-2020·2020-06-10

    FDA Recalls Sterile Surgical Kits from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical kits because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2188-2020·2020-06-10

    Osteomed Recalls Osteovation 5cc Impactformula Bone Void Filler Kits

    Osteomed is recalling Osteovation 5cc Impactformula bone void filler kits because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2020·2020-06-10

    Abbott Afinion 2 Power Supply Recall for Electrostatic Discharge Risk

    Abbott is recalling Afinion 2 and Alere Afinion AS100 power supplies due to a risk of electrostatic discharge and sparking that can render the unit non-functional.

    Product
    Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2189-2020·2020-06-10

    Osteomed Recalls Osteovation RMX Injectable Bone Void Filler Kits

    Osteomed is recalling 278 units of Osteovation RMX Injectable Bone Void Filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.

    Product
    OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1289-2020·2020-06-10

    AvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence

    AvKARE Inc. is recalling 4,124 bottles of Lamotrigine 150 mg tablets because they contain foreign substance consistent with desiccant pack granules.

    Product
    LAMOTRIGINE — LAMOTRIGINE (LAMOTRIGINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2020·2020-06-10

    Inpeco Aptio Automation System Recall for Firmware Error Recovery Defect

    Inpeco S.A. is recalling 61 Aptio Automation Systems because a firmware error recovery procedure may dilute primary sample tubes with distilled water.

    Product
    Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Kits Due to Shelf-Life Error

    Osteomed, LLC is recalling Osteovation 10 CC Impact Formula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2020·2020-06-10

    Trividia True Metrix Air Blood Glucose Meter Recall for Unit Error

    One True Metrix Air blood glucose meter is being recalled because it displays results in mmol/L instead of mg/dL.

    Product
    TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2187-2020·2020-06-10

    Osteomed Recalls Osteovation 3CC ImpactFormula Bone Void Filler Kits

    Osteomed is recalling 409 units of Osteovation 3CC ImpactFormula bone void filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.

    Product
    OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2250-2020·2020-06-10

    Nobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error

    Nobel Biocare is recalling specific dental implant healing abutments because they were packaged with the wrong size device.

    Product
    Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 436 units of Osteovation 10cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1284-2020·2020-06-10

    Triova Recalls Estriol USP Micronized 5 G Due to Impurities

    Triova Pharmaceuticals is recalling Estriol USP Micronized 5 G because the product failed specifications for organic impurities.

    Product
    Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1286-2020·2020-06-10

    Teva Recalls Mixed Amphetamine Salts Tablets Due to Strength Variations

    Teva Pharmaceuticals is recalling 41,348 bottles of 15 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2245-2020·2020-06-10

    Philips Chest Pneumograph Recalled for Missing Natural Rubber Latex Labeling

    Philips is recalling 1,075 Chest Pneumograph units because the labeling fails to state that the product contains natural rubber latex.

    Product
    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling Osteovationex 3cc Inject Formula bone void fillers because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2020·2020-06-10

    Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath

    Bard Peripheral Vascular Inc is recalling 215 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.

    Product
    EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2182-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 647 units of Osteovationex 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2251-2020·2020-06-10

    Abbott Accelerator APS Aliquoter Module Recalled for Sample Dilution Risk

    Abbott is recalling 11 Accelerator APS Aliquoter Modules because a clot detection error may cause distilled water to dilute samples, leading to incorrect clinical results.

    Product
    Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V340000·2020-06-09

    Mercedes-Benz Metris Recall for Driveshaft Attachment Defect

    Daimler Vans USA is recalling 2019 Mercedes-Benz Metris vans because the driveshaft may not be attached correctly, risking loss of drive or unexpected airbag deployment.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V337000·2020-06-09

    Jayco Recalls 2020 Motorized RVs Due to Window Glass Detachment Risk

    Jayco is recalling 2020 motorized recreational vehicles because the adhesive on frameless windows may fail, allowing glass to detach and become a projectile.

    Product
    JAYCO — JAYCO, ENTEGRA REDHAWK, QWEST, SENECA, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V335000·2020-06-09

    ARBOC Spirit of America and Liberty Buses Recalled for Fire Risk

    ARBOC is recalling 113 Spirit of America and Spirit of Liberty buses because misrouted power cables may short circuit, increasing the risk of a fire.

    Product
    ARBOC — ARBOC SPIRIT OF AMERICA, SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V334000·2020-06-09

    Chrysler Recalls 2017-2020 Pacifica Plug-in Hybrids for Fire Risk

    Chrysler is recalling 2017-2020 Pacifica Plug-in Hybrids because a high-resistance electrical connection may overheat and cause a fire.

    Product
    CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V338000·2020-06-09

    Highland Ridge RV Recalls 2020 Trailers Due to Window Glass Detachment Risk

    Highland Ridge RV is recalling 80 units of 2020 Ridge, Open Range, and Silverstar trailers because window glass may detach and become a projectile.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT, HIGHLAND RIDGE FW MESA RIDGE, OPEN RANGE, SILVERSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V339000·2020-06-09

    2020 Thor Motor Coach motorhome frameless windows may detach while driving

    Thor Motor Coach is recalling certain 2020-2021 motorhomes because the adhesive bond in frameless windows may fail, allowing the glass to detach and become a projectile hazard while the vehicle is in motion.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH AXIS, COMPASS, DELANO, GEMINI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V336000·2020-06-09

    Jayco Recalls 2020 Recreational Vehicles Due to Window Glass Detachment Risk

    Jayco is recalling 2020 Eagle, Jay Flight, and other models because window glass may detach and become a projectile.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL, JAYCO TRAVEL TRAILER EAGLE, JAY FLIGHT, EAGLE HT, NORTH POINT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V333000·2020-06-09

    Lion Recalls 2012-2020 School Buses for Seat Belt Anchor Defect

    Lion Electric Company is recalling 2012-2020 Lion 360 and Lion C school buses because the driver's seat belt anchor may be attached with incorrect hardware, potentially compromising safety in a crash.

    Product
    LION — LION 360, LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V331000·2020-06-08

    Ford Recalls Vehicles Due to Door Latch Repair Defects

    Ford is recalling specific 2011-2016 vehicles because previous door latch repairs may have been incomplete, potentially allowing doors to open while driving.

    Product
    FORD — FORD, LINCOLN C-MAX, FIESTA, FOCUS, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E034000·2020-06-08

    Maxon Lift Gates Recalled for Non-Compliant License Plate Light

    Maxon Lift Corp. is recalling specific lift gates where the license plate light may aim rearward, failing federal safety standards and increasing crash risk.

    Product
    STRUCTURE:BODY:HATCHBACK/LIFTGATE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V329000·2020-06-05

    Mercedes-Benz Recalls 2020 GLE and GLS Models for Suspension Defect

    Mercedes-Benz is recalling 2020 GLE 450, GLS 450, and GLS 580 4MATIC vehicles because leaking suspension components may affect handling and increase crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 450, GLS 450, GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V328000·2020-06-05

    Mercedes-Benz Recalls 2020 Models for Rear Seatback Latch Defect

    Mercedes-Benz is recalling 2020 E450, GLC300, and AMG models because the left-rear seatback latch may fail, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, GLC 300, AMG E63S, AMG GLC63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V327000·2020-06-05

    Class C Motorhome Manual Error Increases Rollaway Risk for 2019–2021 Models

    Jayco is recalling certain 2019–2021 Class C motorhomes because the Operator's Manual contains incorrect information about the automatic parking function, which could lead to unintended vehicle movement or rollaway.

    Product
    ENTEGRA — ENTEGRA, JAYCO QWEST, MELBOURNE, MELBOURNE PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V323000·2020-06-04

    Braun Recalls 2019-2020 Demers Ambulances for Rear Brake Line Wear

    Braun Ambulances is recalling 31 Demers ambulances because a rear brake line may wear, causing brake failure and increasing crash risk.

    Product
    DEMERS AMBULANCES — DEMERS AMBULANCES TYPE I (MXP150E), TYPE I (MXP170E)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V324000·2020-06-04

    GM Recalls 2020 Chevrolet and GMC Trucks for Hood Latch Defect

    General Motors is recalling 2020 Chevrolet Silverado and GMC Sierra trucks because improperly heat-treated hood-latch striker wires may fracture, allowing the hood to open while driving.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 3500, SILVERADO 2500, SIERRA 3500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V325000·2020-06-04

    Land Rover Recalls 2016 Range Rover Models for Door Latch Defect

    Jaguar Land Rover is recalling 2016 Range Rover and Range Rover Sport vehicles because a previous repair may have failed, allowing the left door to remain unlatched.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V326000·2020-06-04

    Honda Recalls 2019 Clarity Vehicles Due to Rear Seat Belt Defect

    Honda is recalling 2019 Clarity Fuel Cell, Electric, and Plug-in Hybrid vehicles because the rear seat belt locking mechanism may not function as intended, increasing injury risk in a crash.

    Product
    HONDA — HONDA CLARITY FUEL CELL, CLARITY PLUG-IN HYBRID, CLARITY ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20749·2020-06-04

    Tim Trading Recalls Emori Wintergreen Essential Oil Due to Packaging Defect

    Tim Trading is recalling Emori Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Emori Wintergreen 100% Pure Essential Therapeutic Grade Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2055-2020·2020-06-03

    Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage

    Heartware, Inc. is recalling 2,614 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0960-2020·2020-06-03

    Ritz Cheese Cracker Sandwiches Recalled for Undeclared Peanut Allergen

    Mondelez Global LLC is recalling Ritz Cheese Cracker Sandwiches, Family Size, due to undeclared peanut allergen. The product was distributed throughout the United States.

    Product
    RITZ Cheese Cracker Sandwiches , Family Size , (21.6 oz. carton)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2107-2020·2020-06-03

    MPS Top Cover Replacement Kit Recalled Due to Swapped Labels

    Quest Medical is recalling MPS Top Cover Replacement Kits because additive and arrest agent labels were swapped, posing a risk of over-delivering potassium during surgery.

    Product
    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2146-2020·2020-06-03

    Biomet Recalls Regenerex Knee Prostheses Due to Potential Endotoxin Levels

    Biomet is recalling 15 units of Regenerex Series-A Patella knee prostheses due to potential endotoxin levels exceeding specifications.

    Product
    Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2057-2020·2020-06-03

    Heartware HVAD Pump Implant Kit Recalled for Graft and Screw Defects

    Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2059-2020·2020-06-03

    Heartware HVAD Pump Implant Accessories Recalled for Potential Component Failure

    Heartware, Inc. is recalling HVAD Pump Implant accessories due to potential tears in the outflow graft and breakage of the strain relief screw during assembly.

    Product
    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2118-2020·2020-06-03

    Clinical Innovations Recalls Clearview Total Uterine Manipulator Due to Defective Tip Support

    Clinical Innovations is recalling 280 Clearview Total Uterine Manipulators (model UM750) because a missing notch on the tip support may prevent proper attachment of surgical components.

    Product
    Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2128-2020·2020-06-03

    Siemens Cios Spin X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.

    Product
    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2056-2020·2020-06-03

    Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage

    Heartware, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.

    Product
    Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2039-2020·2020-06-03

    Medtronic Confida Expandable Sheath Recalled for Vascular Complication Risk

    Medtronic is recalling 103 units of the Confida Expandable Sheath due to an increased risk of vascular complications, including bleeding, hematoma, and dissection.

    Product
    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2126-2020·2020-06-03

    Thermo Fisher Recalls Non-Sterile Bio-Tite Specimen Containers

    Thermo Fisher Scientific is recalling 78,600 Bio-Tite specimen containers that were not irradiated and are not sterile.

    Product
    Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2150-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Tibial Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 46 units of Vanguard Knee System tibial bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide

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