The Recall Desk

Archive

October 2020 recalls

622 recalls were announced in October 2020.

What the numbers show

Critical
84
Severe
123
High
313
Moderate
83
Low
19

Of the 622 recalls this month scored against our rubric, 14% are Critical, 20% are Severe.

201–300 of 622

  • HighFDA (Devices)·Z-0162-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent the NanoClave spike from sealing properly.

    Product
    99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2021·2020-10-28

    Smith & Nephew Recalls Microraptor Regenesorb Suture Anchors for Seal Issues

    Smith & Nephew is recalling Microraptor Regenesorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.

    Product
    MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(01)10887709065069(17)250201(30)50(10)4733564. The Intravascular Administration Set is a single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2021·2020-10-28

    Encore Medical Recalls EMPOWR Acetabular Cups Due to Machining Defect

    Encore Medical is recalling 12 EMPOWR Acetabular Cups due to a manufacturing defect that prevents proper seating. The affected cups were distributed nationwide in specific U.S. states.

    Product
    EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indication
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2021·2020-10-28

    ICU Medical Recalls SURPLUG Nano Connectors Due to Manufacturing Defect

    ICU Medical is recalling SURPLUG Nano Connectors because a manufacturing defect on the internal surface of the NanoClave may inhibit a proper seal with the spike.

    Product
    SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2021·2020-10-28

    Genesis Hand Sanitizer Gel Recalled for CGMP Deviations

    Genesis Partnership Company SA is recalling 15,000 bottles of Genesis Hand Sanitizer Gel due to manufacturing deviations in a facility that produced sub-potent products.

    Product
    Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2021·2020-10-28

    Smith & Nephew Recalls Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling HEALICOIL RSB SA absorbable suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2021·2020-10-28

    Genesis Hand Sanitizer Gel Recalled for CGMP Deviations

    Genesis Partnership Company SA is recalling 5,040 bottles of hand sanitizer gel due to manufacturing deviations in a facility that produced sub-potent products.

    Product
    Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0282-2021·2020-10-28

    Fujifilm Synapse PACS Software Version 5.6.1 Recalled for CT Measurement Error

    Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.

    Product
    Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0141-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX AB 5.0 Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2021·2020-10-28

    Sobel Westex Disposable Isolation Gowns Recalled for Performance Failures

    Sobel Westex is recalling 3,380,850 disposable isolation gowns because they did not meet all performance test requirements. The gowns were distributed nationwide in the U.S.

    Product
    SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0040-2021·2020-10-28

    Killz Germz Hand Sanitizer Recalled for Sub-Potent Alcohol Levels

    Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.

    Product
    Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2021·2020-10-28

    Killz Germz Hand Sanitizer Recalled for Sub-Potent Ethanol Levels

    Genesis Partnership Company SA is recalling Killz Germz Hand Sanitizer because testing showed ethanol levels as low as 62%, below the labeled 70% claim.

    Product
    Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2021·2020-10-28

    Quidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors

    Quidel Corporation is recalling package inserts for the Sofia SARS Antigen FIA test because instructions referencing specific viral transport media may lead to false-positive results.

    Product
    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR 2.3 suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0148-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR 2.3 W 1UB II BLUE absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2021·2020-10-28

    Ethicon Recalls VICRYL Sutures Due to Packaging Mismatch

    Ethicon is recalling VICRYL sutures because the foil package may not match the label and carton. The incorrect suture differs in size, length, and construction.

    Product
    VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0202-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17)250101(30)50(10)4572784. The Intravascular Administration Set is a single us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2021·2020-10-28

    Encore Medical Recalls Mislabeled AltiVate Shoulder Socket Inserts

    Encore Medical is recalling 15 AltiVate Reverse Small Socket Inserts due to mislabeling. The error may cause surgery delays or the need for revision surgery.

    Product
    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0033-2021·2020-10-28

    Bumble Bee and Kirkland Signature Tuna Recalled for Swollen Cans

    Bumble Bee Foods is recalling Solid White Albacore Tuna in Water due to swollen cans found during labeling.

    Product
    Solid White Albacore Tuna in Water; Sold under brand names of Bumble Bee and Kirkland Signature: Bumble Bee NET WT 8-7 oz. (198g) Total 56 oz. (3 lbs 8 oz) 1.59 kg); DR WT 8-5.2 oz. (144g_ total 40..8 oz (2 lb 9 oz) (1.15 kg); For Case UPC 86600-23061, the 8 Pack film U
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0151-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0160-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors

    Smith & Nephew is recalling TWINFIX ULTRA absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0037-2021·2020-10-28

    Panagel Hand Sanitizer Recalled for CGMP Deviations and Sub-Potent Ethanol Risk

    Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer due to CGMP deviations and potential sub-potent ethanol levels.

    Product
    Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2021·2020-10-28

    Smith & Nephew Recalls Healicoil Absorbable Suture Anchors for Seal Defects

    Smith & Nephew is recalling Healicoil absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0120-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump IFU Update for Cleaning Practices

    Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0043-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 408 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0047-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0126-2021·2020-10-28

    Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label

    Invivo Corporation is recalling 12,764 MR Coils because the labels were mistakenly printed with an IPX1 rating symbol, which indicates water ingress protection.

    Product
    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0044-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0049-2021·2020-10-28

    Mylan Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Mylan Pharmaceuticals is recalling specific lots of Candesartan Cilexetil and Hydrochlorothiazide tablets due to out-of-specification organic impurities found during routine stability testing.

    Product
    CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0046-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0045-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 13,248 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0048-2021·2020-10-28

    ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date

    ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0042-2021·2020-10-28

    FDA Recalls Desflurane Liquid for Inhalation Due to Container Leaks

    eVenus Pharmaceutical Laboratories is recalling Desflurane Liquid for Inhalation because the containers may be leaking. The recall affects 9,210 units distributed in Colorado.

    Product
    DESFLURANE — DESFLURANE (DESFLURANE)
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20V660000·2020-10-27

    Suspension snap-ring failure could cause wheel separation on Western Star 4700

    Daimler Trucks is recalling certain 2021 Western Star and Freightliner commercial trucks because the steer axle spindle nut snap-ring may be missing or improperly installed, potentially causing wheel separation and increased crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR CASCADIA, 4900, 5700, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V661000·2020-10-27

    Braun Recalls 2017-2020 Demers Ambulances for Seat Belt Defect

    Braun Ambulances is recalling 2017-2020 Demers TSE and EXE ambulances because the rear seat belt harness may separate from its mounting, increasing injury risk in a crash.

    Product
    DEMERS AMBULANCES — DEMERS AMBULANCES, DEMERS EXE, TSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V657000·2020-10-27

    2021 Jeep Cherokee Front Lower Control Arm Fracture Recall

    Chrysler is recalling certain 2021 Jeep Cherokee vehicles because the front lower control arms may fracture while driving. This can cause loss of steering control and increase the risk of a crash.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E082000·2020-10-27

    Leather on Wheels Recalls Polo Helmets for Impact Protection Defect

    Leather on Wheels is recalling Polo model helmets because they may not adequately reduce impact force, increasing the risk of injury in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V658000·2020-10-27

    Audi Recalls 2018-2020 Q7 Vehicles for C-Pillar Padding Defect

    Audi is recalling 2018-2020 Q7 vehicles because the C-pillar padding may not absorb enough impact in a crash, increasing injury risk for unbelted occupants.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V659000·2020-10-27

    Winnebago Era Recalled for Defective Front Seat Belt Anchor Weld Nut

    Winnebago is recalling 2012-2021 Era 170X vehicles because a weld nut was installed on the wrong side of the seat belt bracket, reducing retention strength.

    Product
    WINNEBAGO — WINNEBAGO ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V656000·2020-10-26

    2019-2021 Forest River Palomino Trailers Antenna Detachment Safety Recall

    Forest River is recalling 2019-2021 Palomino trailers because the antenna wing may not be properly secured, allowing it to detach while moving and create a road hazard.

    Product
    FOREST RIVER — FOREST RIVER PALOMINO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V654000·2020-10-26

    Forest River Cherokee recreational trailers recalled for electrical fire risk

    Forest River is recalling 2019-2021 Cherokee recreational trailers due to inadequate wiring insulation on shore cord inlets, which can increase fire risk. Owners should contact Forest River for recall details.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V655000·2020-10-26

    2021 Forest River Cardinal Fifth-Wheel Trailers: Furnace Exhaust Intrusion Risk

    Forest River is recalling 2021 Cardinal fifth-wheel trailers. The furnace intake sleeve is too short and does not properly connect to the exterior, allowing furnace exhaust to enter the trailer and cause carbon monoxide poisoning.

    Product
    FOREST RIVER — FOREST RIVER CARDINAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V651000·2020-10-23

    Mercedes-Benz Recalls 2020 GLC Models for Steering Wiring Defect

    Mercedes-Benz is recalling 2,533 2020 GLC models because a damaged steering wiring harness could cause loss of power assist or a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 300, AMG GLC63, AMG GLC43, GLC 350 E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V650000·2020-10-22

    GM Recalls 2019-2020 Silverado and Sierra Trucks for Driveshaft Defect

    General Motors is recalling 2019-2020 Chevrolet Silverado and GMC Sierra trucks because a driveshaft joint may not be properly welded, risking separation and loss of propulsion.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SILVERADO 1500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21704·2020-10-22

    Rocky Mountain Oils Recalls Wintergreen Essential Oil and Blends for Packaging Defect

    Rocky Mountain Oils is recalling Wintergreen essential oil and four oil blends because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Wintergreen essential oil, and Pain Ease, Sports Pro, True Blue, Relieve Me oil blends
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0083-2021·2020-10-21

    Country Fresh Cantaloupe Chunks Recalled for Listeria Contamination Risk

    Country Fresh Inc. is recalling specific lots of Cantaloupe Chunks due to potential Listeria monocytogenes contamination. Consumers should check their packages and discard or return the product.

    Product
    Cantaloupe Chunks 16oz UPC 681131180153; Cantaloupe Chunks 10oz UPC 681131180146 packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0080-2021·2020-10-21

    Country Fresh Mango Products Recalled for Listeria Contamination Risk

    Country Fresh Inc. is recalling specific mango products due to potential Listeria monocytogenes contamination. Consumers should check for the specific lot number and UPCs listed.

    Product
    Mango Spears 16 oz UPC 681131180382; Mango 10 oz UPC 681131180375; Mango Chunks 5.5 oz UPC 74641018410 all packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0091-2021·2020-10-21

    Country Fresh Summer Blend Recalled for Listeria Contamination Risk

    Country Fresh Inc. is recalling Summer Blend salad due to potential Listeria monocytogenes contamination. The product was distributed in nine states.

    Product
    Summer Blend 5oz UPC 681131355094 packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0086-2021·2020-10-21

    Country Fresh Pineapple, Grapes, and Mango Blend Recalled for Listeria Risk

    Country Fresh Inc. is recalling 16oz Pineapple, Grapes, and Mango Blend due to potential Listeria monocytogenes contamination. The product was distributed in nine states.

    Product
    Pineapple, Grapes, and Mango Blend 16oz UPC 68113118039
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0016-2021·2020-10-21

    Seneca Cinnamon Apple Crisps Recalled for Salmonella Contamination

    Seneca Foods is recalling Cinnamon Apple Crisps due to potential Salmonella contamination. The recall covers specific brands and sizes distributed nationwide.

    Product
    Cinnamon Apple Crisps packaged under the following Brands and sizes: 1. Seneca, 2.5 ounce, UPC 0 18195-70100 8; 2. Clancy's 2.5 ounce, UPC 41498-27266. 3. Seneca, 0.7 ounce, UPC 0 18195-70140 4 4. Seneca 20 lb. 1" dices, product code 10134
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0015-2021·2020-10-21

    Seafarers Inc Recalls Frozen Yellowfin Tuna Loins Due to Illness Reports

    Seafarers, Inc. is recalling two lots of frozen yellowfin tuna loins after four people became ill with symptoms including rash and diarrhea.

    Product
    Frozen Yellowfin Tuna Loins, Vacuum Packed, Imported and Distributed by Seafarers, Inc, 5-8 LBS, Product of Vietnam
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0108-2021·2020-10-21

    Siemens Artis zee and Q Systems Recalled for Collision Risk

    Siemens Medical Solutions is recalling Artis zee and Artis Q systems because a software defect may cause the equipment to collide with room fixtures or patients.

    Product
    Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN B
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0078-2021·2020-10-21

    Seasonal Fruit Tray 40oz May Be Contaminated With Listeria Monocytogenes

    The FDA is recalling Seasonal Fruit Trays 40oz due to potential Listeria monocytogenes contamination. Consumers should not consume these products until further notice.

    Product
    Seasonal Fruit Tray 40oz UPC 681131180238 packaged in a clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0090-2021·2020-10-21

    Country Fresh Apple Grape Tray Recalled for Listeria Risk

    Country Fresh Inc. is recalling Apple Grape Trays with Caramel Sauce due to potential Listeria monocytogenes contamination.

    Product
    Apple Grape Tray With Caramel Sauce 2 lbs 10oz UPC 68113118012 packaged in clear plastic Tray
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0077-2021·2020-10-21

    Watermelon products recalled due to potential Listeria monocytogenes contamination

    Country Fresh Inc. watermelon products are recalled because they may contain Listeria monocytogenes, a harmful bacterium.

    Product
    Watermelon 10 oz UPC Code: 681131180672; Watermelon 32 oz UPC Code: 681131180689; Watermelon Chunks 42 oz UPC Code: 681131180658; Watermelon Spears 16 oz UPC Code: 681131180665; RaceTrac Watermelon 5.5oz UPC Code: 74641000644 all packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0079-2021·2020-10-21

    Country Fresh Tropical Blend Recalled for Listeria Contamination Risk

    Country Fresh Inc. is recalling Tropical Blend 5oz containers due to potential Listeria monocytogenes contamination. The product was distributed in nine states.

    Product
    Tropical Blend 5oz UPC 68113135100 packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0082-2021·2020-10-21

    Country Fresh Seasonal Trio Recalled for Potential Listeria Contamination

    Country Fresh Inc. is recalling Seasonal Trio products due to potential Listeria monocytogenes contamination. The recall affects specific lots distributed across nine states.

    Product
    Seasonal Trio 32oz UPC 681131180696 packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0089-2021·2020-10-21

    Country Fresh Mixed Apples Recalled for Potential Listeria Contamination

    Country Fresh Inc. is recalling 32oz Mixed Apples due to potential Listeria monocytogenes contamination. The product was distributed in nine states.

    Product
    Mixed Apples 32oz UPC 681131180078 packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0084-2021·2020-10-21

    Country Fresh Pineapple Products Recalled for Listeria Risk

    Country Fresh Inc. is recalling specific pineapple products due to potential contamination with Listeria monocytogenes.

    Product
    Pineapple 32oz UPC 681131180443; Pineapple Chunks 10oz UPC 681131180429; Pineapple Chunks 16oz UPC 681131180467; Pineapple 42oz UPC 681131180436; Pineapple chunks 5.5 oz UPC 74641011862 all packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0092-2021·2020-10-21

    Race Trac Melon Trio may be contaminated with Listeria monocytogenes

    The FDA is recalling Race Trac Melon Trio due to potential Listeria monocytogenes contamination. Consumers should not consume this product until further notice.

    Product
    Race Trac Melon Trio 5.5 oz UPC 74641031945 packaged in clear plastic container
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0081-2021·2020-10-21

    Country Fresh Red Grapes Recalled for Listeria Contamination Risk

    Country Fresh Inc. is recalling specific lots of red grapes due to potential Listeria monocytogenes contamination. Consumers in nine states should discard the product.

    Product
    Red Grapes 10oz UPC 68113118047; Red Grape 5.5oz UPC 74641031976 packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0096-2021·2020-10-21

    Handicare SwiftHook Component Recall for Mobile and Ceiling Lifts

    Handicare AB is recalling SwiftHook components used in mobile and ceiling lifts because the carry bar may detach during use, posing a risk of injury to patients and caregivers.

    Product
    SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2021·2020-10-21

    Alcon Custom-Pak Surgical Packs Recalled for Latex Glove Degradation

    Alcon is recalling 16,971 Custom-Pak Surgical Procedure Packs containing Cardinal Health PROTEXIS Latex Micro Surgical Gloves due to a degradation defect that could cause holes or tears.

    Product
    Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0085-2021·2020-10-21

    Seasonal Blend products recalled due to potential Listeria monocytogenes contamination

    The FDA is recalling Seasonal Blend products because they have the potential to be contaminated with Listeria monocytogenes.

    Product
    Seasonal Blend 10oz UPC 68113118048; Seasonal Blend 16oz UPC 681131180498; Seasonal Blend 32oz UPC 681131180504 all packaged in clear plastic containers
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0019-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Muffins Due to Gluten Contamination

    Lucky Spoon Bakery is recalling Gluten Free Utterly Almond Muffins because a flour supplier's batch tested positive for gluten.

    Product
    Lucky Spoon Bakery Gluten Free Utterly Almond Muffins, 7.25 oz. plastic clam shell containing 6 muffins, UPC 8-50489-00305-0, P.O. Box 2954, Salt Lake City, UT 84110. 12 packages/case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0025-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Chocolate Cake Due to Gluten Contamination

    Lucky Spoon Bakery is recalling its Gluten Free Chocolate Celebration Cake because a batch of flour used in production tested positive for gluten.

    Product
    Lucky Spoon Bakery Gluten Free Chocolate Celebration Cake, 17.5 oz. plastic clam shell containing 1 cake, UPC 8-50489-00322-7, P.O. Box 2954 Salt Lake City, UT 84110. 6 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2021·2020-10-21

    Siemens ADVIA Fructosamine Test Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.

    Product
    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0023-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Brownie Bites Due to Gluten Contamination

    Lucky Spoon Bakery is recalling specific lots of Gluten Free Chewy Chocolatey Brownie Bites because a flour supplier's batch tested positive for gluten.

    Product
    Lucky Spoon Bakery Gluten Free Chewy Chocolatey Brownie Bites, 6.6 oz. plastic clam shell containing approximately 12 (6.6 oz.), UPC 8-50489-00315-9, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2021·2020-10-21

    Fresenius AquaBplus Water Purification Systems Recalled for Electrical Safety Defect

    Fresenius Medical Care is recalling 15 AquaBplus water purification systems due to incorrectly crimped connectors that could cause electrical shock.

    Product
    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0024-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Pumpkin Cupcakes Due to Gluten Contamination

    Lucky Spoon Bakery is recalling gluten-free pumpkin cupcakes because a flour batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.

    Product
    Lucky Spoon Bakery Gluten Free Fall Frost Pumpkin Cupcake, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00320-3, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2021·2020-10-21

    Siemens Atellica CH Fructosamine Test Recall for Positive Bias

    Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.

    Product
    Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0091-2021·2020-10-21

    Mizuho OSI Recalls Levo Arms Due to Fluid Ingress Risk

    Mizuho OSI is recalling 174 Levo Arms used in spinal surgery tables due to a potential fluid ingress issue that could cause the locking mechanism to fail.

    Product
    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V647000·2020-10-21

    Braun Ambulances Recall 156 Units Due to Display Lockup

    Braun Ambulances is recalling 156 units because the lighting and HVAC display may lock up, potentially delaying emergency operations and increasing crash risk.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES CHIEF XL TYPE I, RAIDER TYPE I, SUPER CHIEF, EXPRESS PLUS TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2021·2020-10-21

    Genicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance

    Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.

    Product
    Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, Ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0021-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Chocolate Cupcakes Due to Gluten Contamination

    Lucky Spoon Bakery is recalling gluten-free chocolate cupcakes because a flour supplier batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.

    Product
    Lucky Spoon Bakery Gluten Free Chocolate Cupcakes with Vanilla Buttercream Frosting, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00310-4, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0020-2021·2020-10-21

    Lucky Spoon Bakery Recalls Gluten-Free Cupcakes Due to Gluten Contamination

    Lucky Spoon Bakery is recalling gluten-free cupcakes because a flour batch tested positive for gluten. The products were distributed in eight states and nationwide via drop ship.

    Product
    Lucky Spoon Bakery Gluten Free Very Vanilla Cupcakes with Vanilla Buttercream Frosting, 8.0 oz. plastic clam shell containing 4 cupcakes, UPC 8-50489-00309-8, P.O. Box 2954 Salt Lake City, UT 84110. 12 packages/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·21011·2020-10-21

    CB2 Recalls Trace Bookcases Due to Risk of Collapse and Injury

    CB2 is recalling Trace bookcases because the frame can collapse when fully loaded, posing an injury hazard. Consumers should stop using the units and contact CB2 for a replacement or refund.

    Product
    Trace bookcases
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21010·2020-10-21

    Jakks Pacific Recalls MorfBoard Skate Scooters Due to Fall Hazard

    Jakks Pacific is recalling MorfBoard Skate & Scoot Combo scooters with "Y" handlebars because the joint can break, posing a fall hazard.

    Product
    MorfBoard Skate & Scoot Combo scooters with "Y" handlebars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2021·2020-10-21

    SkyVision SDS System Recalled for Intermittent Video Signal Failure

    Skytron is recalling 36 SkyVision SDS System units because intermittent signal failures can cause monitors to go blank during surgery, increasing patient risk.

    Product
    SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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