The Recall Desk

Archive

December 2021 recalls

446 recalls were announced in December 2021.

What the numbers show

Critical
7
Severe
90
High
262
Moderate
74
Low
13

Of the 446 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

101–200 of 446

  • SevereFDA (Devices)·Z-0337-2022·2021-12-22

    FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

    Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.

    Product
    Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V00F000·2021-12-22

    GM Recalls Buick and Chevrolet Vehicles for Rear Suspension Defect

    General Motors is recalling specific Buick and Chevrolet vehicles because rear suspension parts may corrode and fracture, increasing crash risk.

    Product
    BUICK — BUICK, CHEVROLET LACROSSE, REGAL, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0286-2022·2021-12-22

    Al Kanater Tahini Sesame Seeds Recalled for Salmonella

    International Golden Foods Inc is recalling Al Kanater Tahini Sesame Seeds (1 lb plastic bottles) due to potential Salmonella contamination. The affected product was distributed to retailers and distributors in Illinois and Michigan.

    Product
    Al Kanater Tahini Sesame Seeds. 1 Lb plastic bottle. UPC 6-92551-00002-0
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0336-2022·2021-12-22

    Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

    Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

    Product
    Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0280-2022·2021-12-22

    Lidocaine Topical Solution Recalled for Superpotency

    Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0322-2022·2021-12-22

    Country Time Lemonade Drink Mix Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Country Time Lemonade drink mix powder in five sizes due to potential contamination with glass and metal fragments. The recall affects approximately 289,221 cases distributed nationwide and internationally.

    Product
    Country Time Lemonade drink mix powder 19 oz. UPC 043000951170 29 oz. UPC 043000951194 63 oz. UPC 043000082195 82.5 oz. UPC 043000928608 116 oz. UPC 043000075388
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0358-2022·2021-12-22

    Livia One Organic Daily Topical Spray Probiotics recalled for Pseudomonas contamination

    Livia Global is recalling Livia One Organic Daily Topical Spray Probiotics because the product may be contaminated with Pseudomonas aeruginosa, a bacterium that can cause infection.

    Product
    Livia One Organic Daily Topical Spray Probiotics; 4 oz. (120 ml) UPC: 0 30915 10710 5 Recommended use: Topical: Spray affected area 2-5 times daily as needed. Ingredients: Proprietary probiotic blend in an enzyme enriched substrate: Lactobacillus-Acidophilus, L. Rhamn
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0359-2022·2021-12-22

    Neuro Convenience Kit recalled due to expired injectable component

    Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.

    Product
    Neuro Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2022·2021-12-22

    Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect

    Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise

    Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0386-2022·2021-12-22

    Activforce 2 force measurement device recalled for inaccurate measurement

    Activforce 2 medical devices (145 units) are being recalled due to a manufacturing defect causing inaccurate force measurement, which may lead to incorrect treatment planning. Verify your device's serial number against the FDA recall list.

    Product
    activforce 2 package labeling: Model: Activ5-M R 201-200563
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0367-2022·2021-12-22

    MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk

    Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.

    Product
    MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0369-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

    Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2022·2021-12-22

    X-ray therapy applicator base plates may detach from device body

    Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.

    Product
    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0372-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2022·2021-12-22

    Medline Vascular CDS Kit Recalled for Expired Saline Component

    Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.

    Product
    Major Vascular CDS Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2022·2021-12-22

    Surgical Gowns Recalled Due to Potential Packaging Seal Defects

    Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22038·2021-12-22

    Pearl River Propane Hoses Recalled for Fire Hazard Risk

    Pearl River propane hoses used with Flame King torches can swell and rupture, leaking propane gas and creating a fire hazard. About 43,000 units sold online from January through May 2021 are affected.

    Product
    Pearl River propane hoses used on propane torches and accessories
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2022·2021-12-22

    Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals

    Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.

    Product
    Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2022·2021-12-22

    Smith & Nephew EVOS femur plates recalled for erroneous MRI instructions

    Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.

    Product
    smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0282-2022·2021-12-22

    Krispy Kreme Doughnut Bites recalled for metal fragments

    Krispy Kreme is recalling DOUGHNUT Bites Original Glazed in a 5-pouch 8 oz box because the product may contain metal fragments. Consumers who have purchased the affected lot should not eat the product.

    Product
    Krispy Kreme DOUGHNUT Bites ORIGINAL GLAZED 5 1.6 OZ (45g) POUCHES NET WT. 8 OZ (227g) Manufactured under the authority of Krispy Kreme Doughnut Corporation Winston-Salem, NC 27102 UPC 0 72470 00320 1
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0358-2022·2021-12-22

    EVLP Convenience Pack Recalled for Expired Injectable Component

    Medline Industries is recalling EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.

    Product
    EVLP Convenience Pack/Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00G000·2021-12-22

    Alamo Recalls 2012-2021 Schwarze CNG Street Sweepers for Fire Risk

    Alamo Group is recalling 2012-2021 Schwarze A7, A8, and A9 CNG street sweepers because debris accumulation against the exhaust system increases the risk of a fire.

    Product
    SCHWARZE — SCHWARZE A7 CNG STREET SWEEPER, A8 CNG STREET SWEEPER, A9 CNG STREET SWEEPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2022·2021-12-22

    Boston Scientific ROTAPRO System Console Recalled for Manufacturing Instruction Deficiency

    Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.

    Product
    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2022·2021-12-22

    SmartGown Breathable Surgical Gowns recalled for packaging seal defects

    Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.

    Product
    SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2022·2021-12-22

    Medline Venous Access Pack-LF Recalled for Expired Saline Component

    Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

    Product
    Venous Access Pack-LF Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2022·2021-12-22

    EVOS Medial Distal Femur Plate IFU contains erroneous MRI scanning conditions

    Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.

    Product
    smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2022·2021-12-22

    Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

    Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2022·2021-12-22

    Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals

    Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0379-2022·2021-12-22

    Olympus EVIS EXERA II Duodenovideoscope Recalled for Contamination Risk

    Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.

    Product
    EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0284-2022·2021-12-22

    Ripple Dairy-Free Plant-Based Milk Recalled for Bacillus Cereus

    Ripple Foods is recalling 48 fl oz bottles of Ripple Dairy-Free Plant-Based Milk due to the detection of Bacillus Cereus in one lot. The contamination was identified during an FDA investigation.

    Product
    Ripple Dairy-Free. As It Should Be 8g Plant Based Protein; Half the Sugar of Dairy Milk PET bottle with twist cap 50% More Calcium that Dairy Milk. Keep refrigerated. Fresh for 7-10 days after opening. 48 fl oz. (1.5 qt) ((1.42L) - 6 x 48 ox. bottles per case Ingredients: Wate
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0359-2022·2021-12-22

    Livia One Organic Probiotic Nasal Spray Recalled for Pseudomonas Contamination

    Livia Global is recalling Livia One Organic Probiotic Nasal Spray due to contamination with Pseudomonas aeruginosa, a bacterium that can cause respiratory infection.

    Product
    Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in each nostril as needed - 103 times daily as needed. Children 3 and under: It is
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-0324-2022·2021-12-22

    Country Time "On The Go" Lemonade Drink Mix Powder Recall

    Kraft Heinz Foods Company is recalling Country Time "On The Go" Lemonade 10-pack drink mix powder due to potential glass and metal contamination in the product.

    Product
    Country Time "on the go" Lemonade 10 pack net wt. 6.7 oz. drink mix powder UPC 043000010983
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0321-2022·2021-12-22

    Country Time Pink Lemonade Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Country Time Pink Lemonade powder drink mix in 19 oz., 63 oz., and 82.5 oz. packages due to potential glass and metal contamination.

    Product
    Country Time Pink Lemonade powder drink mix 19 oz. UPC 043000951149 63 oz. UPC 043000082188 82.5 oz. UPC 043000928615
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2022·2021-12-22

    Kool-Aid Ice Blue Raspberry Lemonade Drink Mix Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Kool-Aid ice blue raspberry lemonade drink mix powder (20 oz.) due to potential glass and metal contamination in the product.

    Product
    Kool-Aid ice blue raspberry lemonade drink mix powder 20 oz. UPC 043000954072
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0320-2022·2021-12-22

    Kool-Aid Tropical Punch powder drink mix recalled for glass and metal contamination

    Kraft Heinz Foods Company is recalling Kool-Aid Tropical Punch powder drink mix in three sizes due to potential glass and metal contamination in the product.

    Product
    Kool-Aid Tropical Punch powder drink mix 19 oz. UPC 043000953501 63 oz. UPC 043000953501 82.5 oz. UPC 043000957400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0325-2022·2021-12-22

    Country Time Half Lemonade and Half Iced Tea Drink Mix Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Country Time Half lemonade and Half iced tea drink mix powder due to potential glass and metal fragments in the product.

    Product
    Country Time Half lemonade and Half iced tea drink mix powder 19 oz. UPC 043000046005 82.5 oz. UPC 043000046012
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0333-2022·2021-12-22

    Tang Guava Pineapple Drink Mix Powder Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Tang guava pineapple drink mix powder (18 oz.) due to potential glass and metal fragments in the product. Affected packages have a Best When Used By date of 8/13/2023.

    Product
    Tang guava pineapple drink mix powder 18 oz. UPC 043000064511
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2022·2021-12-22

    RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2022·2021-12-22

    Smith & Nephew EVOS Condylar Plate Recalled for Incorrect MRI Instructions

    Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2022·2021-12-22

    Livia One Organic Daily Liquid Probiotics recalled for bacterial contamination

    Livia Global is recalling Livia One Organic Daily Liquid Probiotics in 2 oz. and 4 oz. bottles due to contamination with Pseudomonas aeruginosa, a bacterium that can cause illness.

    Product
    Livia One Organic Daily Liquid Probiotics; 2 oz. (59 ml) and 4 oz. (120 ml) UPC: 0 30915 10711 2 - 2 oz. 0 30915 10716 7 - 4 oz. Recommended use: Internal: Adults 4 droppers full daily. Children 12 yrs and under 1-2 droppers daily. Ingredients: Proprietary prob
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0331-2022·2021-12-22

    Tang Orange Drink Mix Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Tang orange drink mix powder (2.2 kg) due to potential glass and metal contamination. The product was distributed nationwide and internationally.

    Product
    Tang orange drink mix powder 2.2 KG UPC 66188057502
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0280-2022·2021-12-22

    TJ Farms Select Frozen Cauliflower Recalled for Listeria

    FLAGSHIP FOOD GROUP LLC is recalling TJ Farms Select frozen cauliflower due to potential Listeria monocytogenes contamination. The affected product was distributed in Pennsylvania, Tennessee, and Wisconsin.

    Product
    Frozen cauliflower, TJ Farms Select brand, packaged in 16 oz. plastic bag. UPC 7 5544000604 3
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0330-2022·2021-12-22

    Kool-Aid Tropical Punch Drink Mix Recalled for Glass and Metal Contamination

    Kraft Heinz Foods is recalling Kool-Aid Tropical Punch "on the go" 10-pack drink mix powder due to potential contamination with glass and metal fragments. The affected product was distributed nationwide and internationally.

    Product
    Kool-Aid Tropical Punch "on the go" 10 pack net wt. 6.6 oz. drink mix powder UPC 043000023464
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2022·2021-12-22

    Arizona Arnold Palmer Drink Mix Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Arizona Arnold Palmer Half Iced Tea & Half Lemonade drink mix powder (73 oz) because the product may contain glass and metal fragments.

    Product
    Arizona Arnold Palmer Half Iced Tea & Half Lemonade drink mix powder 73 oz. UPC 043000086643
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2022·2021-12-22

    FDA Updates Instructions for Miami J Select Collar Device

    Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.

    Product
    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2022·2021-12-22

    Yeast Extract Ajirex Recalled for Potential Salmonella Contamination

    Mitsubishi International Food Ingredients is recalling Yeast Extract Ajirex in 15 kg bags due to potential Salmonella contamination. The product was distributed to Georgia, Illinois, Pennsylvania, and Texas.

    Product
    Yeast Extract Ajirex in 15 kg PE bag in carton box
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0385-2022·2021-12-22

    Activ5 Smart Fitness Device Recalled for Inaccurate Force Measurement

    Activbody is recalling the Activ5 smart fitness device due to manufacturing defects causing inaccurate force measurements, which may lead to incorrect treatment planning. The device was distributed nationwide.

    Product
    Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics-based smart strength training and rehabilitation device.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-0377-2022·2021-12-22

    Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

    Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2022·2021-12-22

    Cook Flexor Check-Flo Introducer recalled for size mislabeling

    Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0384-2022·2021-12-22

    BioGlue Surgical Adhesive recalled for unauthorized distribution in European Union

    CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.

    Product
    BioGlue Surgical Adhesive, Model BG3510-5-G
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0284-2022·2021-12-22

    B-Complex Injection Recalled Due to Lack of Processing Controls

    Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.

    Product
    B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0388-2022·2021-12-22

    Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size

    Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0390-2022·2021-12-22

    Medical Device ID Cards incorrectly printed with MR conditional system statement

    Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.

    Product
    Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0282-2022·2021-12-22

    Clindamycin and Benzoyl Peroxide Gel Recalled for Superpotent Formulation

    TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, nationwide due to a superpotent (higher-than-intended active ingredient) formulation. The voluntary recall affects three specific lots.

    Product
    Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0285-2022·2021-12-22

    Telmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency

    Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg due to superpotency. The affected batch (BZ74G001, expiring 12/2021) contains approximately 27,312 bottles distributed nationwide.

    Product
    Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2022·2021-12-22

    Astra XT DR Patient Identification Cards Printed with Incorrect MR Statement

    Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.

    Product
    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0362-2022·2021-12-22

    Bedside PICC CDS Convenience Kit Recalled for Expired Saline Component

    Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.

    Product
    Bedside PICC CDS Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0278-2022·2021-12-22

    Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0279-2022·2021-12-22

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0332-2022·2021-12-22

    Tang Orange Drink Mix Powder Recall for Potential Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Tang orange drink mix powder in three sizes due to potential contamination with glass and metal particles. The affected product was distributed nationwide and internationally.

    Product
    Tang orange drink mix powder 20 oz. UPC 043000032275 58.9 oz. UPC 043000082171 72 oz. UPC 043000032268
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0327-2022·2021-12-22

    Kool-Aid Cherry Drink Mix Powder Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Kool-Aid cherry drink mix powder in multiple sizes due to potential glass and metal contamination. The recall affects 289,221 cases distributed nationwide and internationally.

    Product
    Kool-Aid cherry drink mix powder 19 oz. UPC 043000953532 19 oz. UPC 043000034163 63 oz. UPC 043000082201
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0281-2022·2021-12-22

    Lidocaine Hydrochloride Topical Solution recalled for CGMP deviations

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2022·2021-12-22

    Bartels Legionella Urinary Antigen test recalled due to reagent contamination

    Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.

    Product
    Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0329-2022·2021-12-22

    Kool-Aid Strawberry Drink Mix Recalled for Glass and Metal Contamination

    Kraft Heinz Foods Company is recalling Kool-Aid strawberry drink mix powder (19 oz.) due to potential glass and metal contamination. The recall affects approximately 289,221 cases distributed nationally and internationally.

    Product
    Kool-Aid strawberry drink mix powder 19 oz. UPC 043000953556
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0319-2022·2021-12-22

    Mother's Milk Bank of North Texas Pasteurized Donor Human Milk Recalled for Foreign Object

    Mother's Milk Bank of North Texas is recalling 54 bottles of pasteurized donor human milk (100 mL each, batch 025958-1) distributed in Texas because a foreign object was found in a bottle.

    Product
    Mother's Milk Bank of North Texas 817-810-0071 Pasteurized Donor Human milk Volume: 100mL 1.00 g/dL Protein packaged in sterile BPA free plastic bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0283-2022·2021-12-22

    Methylcobalamin Injection Recalled Due to Lack of Processing Controls

    Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.

    Product
    Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Food)·F-0334-2022·2021-12-22

    Morton Iodized Salt Lacks Required Iodine Fortification

    Morton Iodized Salt labeled as iodized actually contains salt without iodine fortification. The recall affects 16,920 canisters distributed to retailers in Colorado and California.

    Product
    Morton Iodized Salt, Net Wt. 26 oz (1 LB 10 OZ) 737 g, Morton Salt, Inc. Chicago, IL 60606
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0283-2022·2021-12-22

    The Mustard Man Inc Simply Peppered Mustard Wrong Product Packaging

    The Mustard Man Inc is recalling Simply Peppered Mustard bottles that were incorrectly filled with Simply Horsey Mustard instead. The product was distributed in eight states and should not be consumed.

    Product
    The Mustard Man Inc Simply Peppered Mustard 8oz plastic bottles, 6 bottles per case
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·21V00B000·2021-12-21

    Tesla Model S Hood Latch Misalignment Could Cause Unexpected Hood Opening During Driving

    Tesla is recalling 2014-2021 Model S vehicles due to a misaligned front trunk latch assembly that may prevent the secondary hood latch from engaging. This could allow the hood to open unexpectedly during driving, obstructing the driver's view and increasing crash risk.

    Product
    TESLA — TESLA MODEL S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00A000·2021-12-21

    2022 Jeep Wagoneer and Grand Wagoneer Rearview Display Software Defect

    Certain 2022 Jeep Wagoneer and Grand Wagoneer vehicles have a radio software defect that may prevent the rearview camera display from functioning, reducing rear visibility and increasing crash risk. Dealers will reprogram the radio software free of charge.

    Product
    JEEP — JEEP GRAND WAGONEER, WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V995000·2021-12-20

    Van Hool Recalls 2020-2021 Buses Due to Fuel Leak Fire Risk

    Van Hool is recalling 139 CX45, TX45, and TDX25 buses because fuel tubes may crack, causing high-pressure leaks that could lead to fire.

    Product
    VAN HOOL — VAN HOOL CX45, TX45, TDX25
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V998000·2021-12-20

    Altec Recalls 2017-2021 Aerial Devices Due to Hydraulic Plumbing Defect

    Altec Industries is recalling 2017-2021 aerial devices because incorrect hydraulic plumbing could allow booms to overextend, increasing the risk of tipping and injury.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V996000·2021-12-20

    Crane Carrier Recalls LET2 Trucks Due to Fuel Leak Fire Risk

    Crane Carrier is recalling 2019-2021 LET2 vehicles because fuel tubes may crack, causing a high-pressure leak that increases fire risk.

    Product
    CRANE CARRIER — CRANE CARRIER, CRANE LET2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V999000·2021-12-20

    2022 Thomas Built Minotour School Buses Recalled for Wheelchair Lift Defect

    Daimler Trucks North America is recalling 2022 Thomas Built Minotour School Buses because the parking brake may release while the wheelchair lift is deployed, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V997000·2021-12-20

    2022 Entegra Vision Motorhomes Recalled for Melting Wiring Harness

    Jayco is recalling certain 2022 Entegra Vision motorhomes because the main chassis wiring harness may be positioned too close to the exhaust manifold, causing the wiring to melt. This can lead to vehicle stall and increased crash risk.

    Product
    JAYCO — JAYCO, ENTEGRA ALANTE, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V993000·2021-12-20

    Cruiser Recalls 2021-2022 Travel Trailers for Incorrect Tire Labeling

    Cruiser RV is recalling 2021-2022 Shadow Cruiser and 2022 Twilight travel trailers because certification labels may display incorrect tire information, potentially leading to the installation of wrong tires.

    Product
    CRUISER RV — CRUISER RV, CRUISER SHADOW CRUISER, TWILIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-12182021-02·2021-12-18

    Frozen Wonton Soup Products Recalled for Undeclared Shrimp and Pork Allergens

    USDA FSIS issued a public health alert for Trader Ming's frozen wonton soup containing undeclared shrimp and pork. Consumers with allergies should not consume the product.

    Product
    Fortune Avenue Foods, Inc. — FSIS Issues Public Health Alert for Frozen Wonton Soup Products Due to Undeclared Allergens and Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-12182021-01·2021-12-18

    Swiss Meat Hawaiian Summer Sausage Alerted for Metal Contamination

    USDA FSIS issued a public health alert for Swiss Meat Hawaiian-style summer sausage due to possible metal contamination. Consumers are urged not to consume the product.

    Product
    Swiss Processing Plant Inc. — FSIS Issues Public Health Alert for Summer Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21V990000·2021-12-17

    2020 Mercedes-Benz A220 suspension recall due to corroding axle carrier

    Mercedes-Benz is recalling certain 2019-2020 A220 and other model vehicles because the front axle carrier may corrode and fail, potentially causing loss of steering control. Dealers will inspect and replace the carrier for free.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLB35, GLB 250, A 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V988000·2021-12-17

    Forest River Cardinal fifth wheel vehicles recalled for carbon monoxide risk

    Forest River is recalling 2020-2022 Cardinal fifth wheels because the generator compartment may not be properly sealed, potentially allowing carbon monoxide into the vehicle. Owners should contact dealers for free inspection and repair.

    Product
    FOREST RIVER — FOREST RIVER CARDINAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V989000·2021-12-17

    Mercedes-Benz Recalls One 2020 CLA 250 for Steering Defect

    Mercedes-Benz is recalling one 2020 CLA 250 because melted adhesive may contaminate the power steering connection, risking assist failure.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V974000·2021-12-16

    Arrow Manufacturing Recalls Ram 4500 and 5500 Chassis for Brake Leak

    Arrow Manufacturing is recalling 2019-2021 Ram 4500 and 5500 cab chassis because a brake line may leak, risking brake loss and crashes.

    Product
    ARROW MANUFACTURING — ARROW MANUFACTURING RAM 5500, RAM 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22712·2021-12-16

    Northern Lights Alaura Two-Tone Jar Candles Recall Due to Laceration and Fire Hazards

    Northern Lights is recalling Alaura Two-Tone Jar Candles sold at Costco because the glass containers can shatter, crack, or break while burning, posing laceration and fire hazards. The company has received 138 reports of breakage, including three reports of laceration injuries.

    Product
    Alaura Two-Tone Jar Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V979000·2021-12-16

    2021-2022 Ford Mustang Mach-E and 2022 Maverick seat belt attachment recall

    Ford is recalling 2021-2022 Mustang Mach-E and 2022 Maverick vehicles due to improperly attached rear seat belt buckles. The defect may prevent proper occupant restraint in a crash, creating an injury risk.

    Product
    FORD — FORD MUSTANG MACH E, MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E101000·2021-12-16

    Bosch High Pressure Fuel Pump Recall for Engine Stall Risk

    Robert Bosch is recalling high pressure fuel pumps for BMW and Chrysler vehicles due to a risk of sudden engine stall while driving.

    Product
    FUEL SYSTEM, DIESEL:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V986000·2021-12-16

    Ford Recalls 2021-2022 F-150 Trucks for Driveshaft Fracture Risk

    Ford is recalling 2021-2022 F-150 vehicles because underbody insulators may loosen and damage the driveshaft, potentially causing loss of vehicle control.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V981000·2021-12-16

    Terex Advance Mixer Trucks Recalled for Fuel Leak Fire Risk

    Terex is recalling 2016-2022 Front Discharge Mixer trucks because fuel tubes may crack, causing high-pressure leaks that increase fire risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V983000·2021-12-16

    Ford Recalls 2018 F-150 Trucks for Tailgate Latch Defect

    Ford is recalling 2018 F-150 trucks because tailgate latches may open unexpectedly while driving, creating a road hazard.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V985000·2021-12-16

    Chevrolet and GMC Trucks: Spare Tire Incompatibility Disables Braking System

    General Motors is recalling certain 2019-2021 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks. The supplied 17-inch spare tire is incompatible with aftermarket wheels, disabling the anti-lock braking system and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide

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