The Recall Desk

Archive

February 2023 recalls

503 recalls were announced in February 2023.

What the numbers show

Critical
6
Severe
69
High
395
Moderate
32
Low
1

Of the 503 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

Which agencies issued them

301–400 of 503

  • SevereFDA (Devices)·Z-0963-2023·2023-02-08

    CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms

    Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.

    Product
    CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2023·2023-02-08

    CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms

    Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0962-2023·2023-02-08

    CADD Administration Set recall: medication underdelivery and false alarms

    Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.

    Product
    CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2023·2023-02-08

    Non-sterile orthopedic procedural trays recalled for potential sterile packaging breach

    Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.

    Product
    Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·23115·2023-02-08

    Fabuloso Multi-Purpose Cleaners Recalled for Bacterial Contamination Risk

    Colgate-Palmolive is recalling about 4.9 million Fabuloso Multi-Purpose Cleaners due to contamination with Pseudomonas bacteria. People with weakened immune systems, external medical devices, or underlying lung conditions face a risk of serious infection from exposure.

    Product
    Fabuloso Multi-Purpose Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02082023-01·2023-02-08

    Goulart's Smoked Linguica Links Recalled for Undeclared Milk Allergen

    USDA FSIS issued a public health alert for Goulart's Smoked Linguica Links due to undeclared milk. Consumers with dairy allergies should not consume these products.

    Product
    Goulart's Sausage Co. — FSIS Issues Public Health Alert for Ready-To-Eat Pork Sausage Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0339-2023·2023-02-08

    Daim Swedish Almond Cake Recalled for Metal Contamination

    Almondy AB is recalling Daim Swedish almond cake (NET WT 14.1oz) due to discovery of a metal object in the product. Consumers should not eat affected cakes.

    Product
    Daim, Swedish almond cake with chocolate and crunchy caramel, Baked by Almondy, NET WT 14.1oz (400g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1051-2023·2023-02-08

    Bard Catheter Repair Kits Recalled for Hardened, Unusable Adhesive

    Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.

    Product
    Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all ex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0318-2023·2023-02-08

    DR SNACK Crystal Ginger recalled for undeclared sulfites

    DR SNACK Crystal Ginger was recalled because the product contains undeclared sulfites. Affected products were distributed in the Northeast U.S.

    Product
    DR SNACK brand Crystal Ginger; Net Wt. 7.00 oz (0.20kg); Net 6oz; and Net 10 oz.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0331-2023·2023-02-08

    Frozen burritos recalled for undeclared milk allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito (Pizza, 5.5 oz) because the product contains undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Alpha Plant-Based Burrito - Pizza 5.5 oz UPC 855099007016 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1027-2023·2023-02-08

    Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators

    Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2023·2023-02-08

    Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling

    Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left;
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0332-2023·2023-02-08

    Frozen Breakfast Burrito Recalled for Undeclared Milk Allergen

    Alpha Plant-Based Burrito products contain undeclared milk that poses an allergen risk. THE MISO BROTHERS INC is recalling 31,092 units distributed throughout US retail locations.

    Product
    Alpha Plant-Based Burrito - Steakless Ranchero 5.5 oz UPC 855099007764 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1025-2023·2023-02-08

    Cardiopulmonary Bypass Oxygenator Recalled for Loose Temperature Monitoring Adapter

    Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2023·2023-02-08

    Frozen Plant-Based Breakfast Sandwich Recalled for Undeclared Milk Allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Breakfast Sandwiches because they contain milk that is not listed on the label. Consumers with milk allergies may experience allergic reactions.

    Product
    Alpha Plant-Based Breakfast Sandwich - Meatless Spicy Chorizo, Plant-Based Egg & Cheeze 5 oz UPC 810070350109 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0330-2023·2023-02-08

    Alpha Plant-Based Burrito Recall: Undeclared Milk Allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Burritos because they contain undeclared milk, a common allergen. Approximately 31,092 units are affected across US retail locations.

    Product
    Alpha Plant-Based Burrito - Philly 5.5 oz UPC 855099007023 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0259-2023·2023-02-08

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer due to manufacturing practice deviations. The recall affects 124 bottles with lot number C013121 distributed in Puerto Rico.

    Product
    Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1044-2023·2023-02-08

    Biopsy Medium for In Vitro Fertilization Recalled Due to Product Contamination

    CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.

    Product
    BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1037-2023·2023-02-08

    Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures

    Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.

    Product
    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2023·2023-02-08

    Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall

    Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1042-2023·2023-02-08

    Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side

    Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1022-2023·2023-02-08

    SynCardia Total Artificial Heart System Recalled for Cannula Tears

    SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.

    Product
    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2023·2023-02-08

    Plant-based breakfast burritos recalled for undeclared milk allergen

    THE MISO BROTHERS INC is recalling 31,092 units of frozen Alpha Plant Based Breakfast Burritos due to undeclared milk. The product may contain milk, a common allergen.

    Product
    Alpha Plant Based Breakfast Burrito - Meatless Sausage SCRAMBLE 5.5 oz UPC 855099007733 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0334-2023·2023-02-08

    Ube Spanish Bread Recalled Due to Undeclared Wheat Allergen

    Joy Joys Bakery LLC recalls Ube Spanish Bread because the label lists 'flour' without specifying it is wheat flour, failing to disclose a major allergen. The product was distributed in Washington and Oregon.

    Product
    Ube Spanish Bread, UPC 36897113. Product is packaged in plastic clear clamshell container and there are 6 pieces per container. Ingredients: Ube Flavoring, Butter, Egg, Flour, Water, Milk, Sugar, Salt, Yeast. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific HW
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0335-2023·2023-02-08

    Ube Ensaymada recalled for undeclared wheat allergen

    Joy Joys Bakery LLC is recalling Ube Ensaymada sold in Washington and Oregon due to undeclared wheat. The product label lists flour but does not specify wheat flour.

    Product
    Ube Ensaymada, UPC 6658266481. Product is packaged in plastic clear clamshell container and there are 4 pieces per container. Ingredients: Cream Cheese, Cheese, Butter, Milk, Sugar, Salt, Water, Yeast, Flour, Egg. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacifi
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0327-2023·2023-02-08

    Frozen breakfast sandwiches and burritos recalled for undeclared milk allergen

    The Miso Brothers Inc. is recalling frozen breakfast sandwiches and breakfast burritos containing undeclared milk, affecting approximately 31,092 units distributed throughout US retail locations. This poses a risk to consumers with milk allergies.

    Product
    Alpha Plant-Based Breakfast Sandwich - Meatless Sausage, Plant-Based Egg & Cheeze 5 oz. UPC 810070350093 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0333-2023·2023-02-08

    Ameripack Foods Chocolate Brownies Recalled for Undeclared Soy and Egg

    Ameripack Foods LLC is recalling Chocolate Chunk Brownies (UPC 4122077413) due to undeclared soy and egg allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chocolate Chunk Brownie 13oz UPC 4122077413 packaged in a metal tray with a clear plastic nonflexible lid, 6 trays per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0336-2023·2023-02-08

    Ube Roll bakery product recall due to undeclared wheat allergen

    Joy Joys Bakery is recalling Ube Roll packages because the label lists 'flour' but does not specify it is wheat flour, creating an allergen risk for consumers with wheat sensitivity.

    Product
    Ube Roll UPC 35961092. Product is packaged in plastic clear clamshell container and there are 3 pieces per container. Ingredients: Ube Flavoring, Butter, Flour, Sugar, Salt, Yeast, Egg, Milk, Water. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific HWY SW Lake
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0325-2023·2023-02-08

    Frozen Breakfast Burritos Recalled for Undeclared Milk Allergen

    The Miso Brothers is recalling Alpha Plant Based Breakfast Burritos because they contain undeclared milk. This poses a risk to consumers with milk allergies or sensitivities.

    Product
    Alpha Plant Based Breakfast Burrito - BAC'N SCRAMBLE 5.5 oz. UPC 855099007948 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0346-2023·2023-02-08

    Organic jackfruit recalled for undeclared sulfites in Florida

    Organic jackfruit produced by Food Castle, Inc. is being recalled due to undeclared sulfites not listed on the product label. Sulfite-sensitive consumers face potential allergic reaction risk.

    Product
    ORGANIC JACKFRUIT Nutty and Fruity Brand UNSWEETENED AND UNSULFURED NET WT. 3.5 oz. (100g) USDA ORGANIC UPC: 819496021426 8 units per case Distributed by: Food Castle Inc. Vernon, CA 90058 PRODUCT OF SRI LANKA
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0329-2023·2023-02-08

    Frozen breakfast burritos recalled for undeclared milk allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito - CHIK'N FAJTA frozen breakfast burritos because they contain undeclared milk that is not listed on the label. The product poses a risk to consumers with milk allergies.

    Product
    Alpha Plant-Based Burrito - CHIK'N FAJTA 5.5 oz UPC 855099007047 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0262-2023·2023-02-08

    Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications

    Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2023·2023-02-08

    GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation

    W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.

    Product
    GORE CARDIOFORM Septal Occluder, REF: GSX0030A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2023·2023-02-08

    Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier

    Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.

    Product
    Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2023·2023-02-08

    Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach

    Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2023·2023-02-08

    Non-sterile procedural trays with potential sterile packaging breach

    Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.

    Product
    Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2023·2023-02-08

    Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery

    The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2023·2023-02-08

    Affinity Fusion Oxygenator adapter may loosen during cardiac surgery

    Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2023·2023-02-08

    OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts

    Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.

    Product
    OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2023·2023-02-08

    Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk

    Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.

    Product
    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2023·2023-02-08

    Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown

    Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.

    Product
    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2023·2023-02-08

    MEDLINE procedural trays recalled for potential sterile packaging breach

    MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.

    Product
    Non-sterile procedural trays labeled as CRANI, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2023·2023-02-08

    Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery

    Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.

    Product
    AxiEM" Non-Invasive Patient Tracker
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1035-2023·2023-02-08

    Non-sterile procedural knee trays recalled for potential packaging breach

    Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.

    Product
    Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2023·2023-02-08

    MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure

    MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.

    Product
    MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2023·2023-02-08

    Procedural Trays with Sterile Blades May Have Damaged Packaging

    Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.

    Product
    Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2023·2023-02-08

    Medline UNITE Foot & Ankle Screw Recalled for Intra-Operative Failure

    Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.

    Product
    MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2023·2023-02-08

    Procedural trays recalled for potential sterile packaging breach

    Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.

    Product
    Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2023·2023-02-08

    Non-sterile procedural trays risk sterile packaging breach

    Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.

    Product
    Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0258-2023·2023-02-08

    Easy Clean Ethyl Alcohol Bottles Recalled Due to Manufacturing Deviations

    Frenda Corporation voluntarily recalled 44,140 bottles of Easy Clean 75% Ethyl Alcohol sold in Puerto Rico due to manufacturing practice deviations.

    Product
    Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0254-2023·2023-02-08

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution due to manufacturing practice deviations. The recall affects 144 bottles distributed in Puerto Rico.

    Product
    Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0257-2023·2023-02-08

    Easy Clean Isopropyl Alcohol Recalled for Manufacturing Practice Deviations

    Frenda Corporation is recalling Easy Clean 70% Isopropyl Alcohol due to manufacturing practice deviations. The recall affects 65,376 bottles distributed in Puerto Rico.

    Product
    Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0323-2023·2023-02-08

    Vitamin B Complex dietary supplement recalled due to undeclared niacin

    Professional Complementary Health Formulas, LLC recalls Vitamin B Complex dietary supplement (lot 1092715) due to undeclared niacin affecting 299 bottles distributed nationwide.

    Product
    Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin) 80
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0337-2023·2023-02-08

    Limited Edition Winter Mint Chocolate Premier Protein Shake Recalled for Spoilage Risk

    Niagara Bottling is recalling Limited Edition Winter Mint Chocolate Premier Protein Shakes distributed in CA, GA, and OH because they did not undergo proper processing and may be spoiled.

    Product
    Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plastic bottles in full wrap lithograph packed in a cardboard case, 12 packages per case
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0261-2023·2023-02-08

    Homeopathic Topical Cream Recalled for Manufacturing Process Deviations

    DISCOVERY PHARMA LLC voluntarily recalled 21,892 tubes of Conzerol zero molluscum contagiosum topical cream distributed in California, Florida, and Washington due to current good manufacturing practice deviations.

    Product
    Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1049-2023·2023-02-08

    Lucid TCD 2.0 Transcranial Ultrasound System Recalled for Hard Drive Failure

    The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.

    Product
    Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2023·2023-02-08

    Biopsy marker device recalled for label and contents mismatch

    Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.

    Product
    Mammotome MammoStar Biopsy Site Identified, REF STAR1401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2023·2023-02-08

    Easy Clean Isopropyl Alcohol Recalled for Manufacturing Deviations

    Frenda Corporation is voluntarily recalling Easy Clean Isopropyl Alcohol 99%, 1-gallon bottles (164 units) due to current Good Manufacturing Practice deviations. The product was distributed in Puerto Rico, lot C030121.

    Product
    Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0322-2023·2023-02-08

    Inositol dietary supplement recalled due to undeclared niacin

    Professional Complementary Health Formulas is recalling Inositol dietary supplement (Lot 1032526, UPC 4065111562) distributed in NY, OR, PA, UT, WI, and WY due to undeclared niacin. Consumers should stop using the product.

    Product
    Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inositol DIETARY SUPPLEMENT 360 Capsules***Supplement Facts Serving Size: One Capsule***Inositol 920 mg***Other Ingredients: Vegetarian capsule (hypro
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0255-2023·2023-02-08

    FDA Recalls Easy Clean Alcohol Surface Disinfectant Due to Manufacturing Deviations

    Frenda Corporation recalls Easy Clean Alcohol Surface Disinfectant Cleaner due to cGMP deviations. The recall affects 8,475 bottles distributed in Puerto Rico.

    Product
    Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1050-2023·2023-02-08

    Ultrasound system hard drive defect causes device freezing and failure

    FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.

    Product
    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0260-2023·2023-02-08

    Global Care 70% rubbing alcohol products recalled for cGMP manufacturing violations

    Global Care 70% Alcohol Ethyl Rubbing Alcohol, distributed in Puerto Rico, has been voluntarily recalled by Frenda Corporation due to manufacturing compliance deviations. The recall affects 12,130 bottles in multiple package sizes.

    Product
    Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·23V056000·2023-02-07

    Pleasant Valley Teardrop Trailers Recalled for Gas Leak Risk

    Pleasant Valley is recalling 2023 Teardrop TAB 320s and TAB 320CSS travel trailers because internal aluminum burner tubes may fracture, causing a gas leak that could lead to fire.

    Product
    PLEASANT VALLEY — PLEASANT VALLEY TEARDROP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V057000·2023-02-07

    Maintainer Service Trucks Recalled for Uncontrolled Crane Movement Risk

    Maintainer is recalling 2019-2023 service trucks with hydraulic cranes because power loss may cause uncontrolled movement, increasing injury risk.

    Product
    MAINTAINER — MAINTAINER CRANE W/ SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E008000·2023-02-07

    Lippert Recalls RV Entry Door Latches Due to Failure Risk

    Lippert is recalling specific RV entry door latches that may fail, preventing entry or exit. This defect increases the risk of injury during an emergency.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V054000·2023-02-06

    Nova Bus Recalls 2022 LFS Transit Buses for Steering Hose Defect

    Nova Bus is recalling 2022 LFS transit buses because the power steering hose may not have been assembled correctly, which can result in hose detachment and a loss of power steering assist.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E007000·2023-02-06

    Tokai Rika Seat Belt Assemblies Recalled for Force-Limiter Defect

    Tokai Rika is recalling certain front-seat outer right-side seat belt assemblies because the force-limiter may not operate correctly. This defect could allow the belt to extend further than intended, increasing injury risk in a crash.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V053000·2023-02-05

    2022 Can-Am Spyder F3 Recalled for Rearview Mirror Lens Detachment

    Bombardier is recalling 2022 Can-Am Spyder F3 and F3-S motorcycles because the rearview mirror lens may detach, reducing rear visibility and increasing crash risk.

    Product
    CAN-AM — CAN-AM SPYDER F3-S, SPYDER F3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V052000·2023-02-04

    Nexus RVs Recalls 2022 Motorhomes Due to Awning Seam Separation Risk

    Nexus RVs is recalling 2022 motorhomes because a welded seam on the electric retractable awning may separate, potentially allowing the awning to drop and increase the risk of injury.

    Product
    NEXUS — NEXUS GHOST, WRAITH, VERRADO, REBEL 4X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·004-2023·2023-02-03

    USDA Recalls Ineligible Frozen Catfish Imported from India

    Delight Foods USA LLC and Delight Foods LLC are recalling approximately 2,961 pounds of frozen catfish imported from India because the country is ineligible to export these products to the U.S.

    Product
    Delight Foods USA LLC Recalls Ineligible Frozen Siluriformes Products Imported from India
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V050000·2023-02-03

    BMW Recalls 2023 760i and i7 Models Due to Airbag Software Defect

    BMW is recalling 397 vehicles because a software error may disable front passenger airbags and active headrests, increasing injury risk in crashes.

    Product
    BMW — BMW 760I, I7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02032023-01·2023-02-03

    Undercooked Ready-to-Eat Stuffed Chicken Product Subject to Public Health Alert

    USDA FSIS issued a public health alert for Park Street Deli broccoli stuffed chicken that may be undercooked. Consumers should not eat the product.

    Product
    Vanguard Culinary Group, Ltd. — FSIS Issues Public Health Alert for Ready-To-Eat Stuffed Chicken Product that May Be Undercooked Due to A Processing Deviation
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·23V051000·2023-02-03

    BMW S 1000 XR and R motorcycles recall for deactivated safety feature

    BMW is recalling 2020-2023 S 1000XR and 2022-2023 S 1000R motorcycles because a software update may have deactivated the front wheel lift-off assistant feature without notifying riders, increasing the risk of unexpected handling and loss of control.

    Product
    BMW — BMW S 1000 XR, S 1000 R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02033023-02·2023-02-03

    Frozen Chicken Korma Recalled for Undeclared Cashews and Misbranding

    USDA FSIS issued a public health alert for Wegmans frozen chicken korma products due to misbranding and an undeclared cashew allergen. No illnesses have been reported.

    Product
    CAFE SPICE LLC — FSIS Issues Public Health Alert for Frozen Chicken Korma with Basmati Turmeric Rice Products Due to Misbranding and An Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·23V049000·2023-02-03

    Winnebago motorhome cooktops recalled for potential gas leak and fire risk

    Winnebago is recalling certain Travato, Solis, and Ekko motorhomes with Suburban cooktops that may develop gas leaks due to fractured burner tubes. In the presence of an ignition source, a leak poses a fire risk.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, EKKO, SOLIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V047000·2023-02-02

    GM Recalls 2017-2019 Chevrolet and GMC Trucks for Fuel Tank Defect

    General Motors is recalling 2017-2019 Chevrolet Silverado and GMC Sierra trucks because a rear fuel tank may collapse, causing the engine to stall and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SIERRA 3500, SIERRA 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V044000·2023-02-02

    Land Rover vehicles recalled for engine oil leak fire risk

    Jaguar Land Rover is recalling certain 2019-2023 Land Rover vehicles because the engine cam carrier oil channel may become blocked, causing an oil leak that could increase fire risk. No injuries have been reported.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER VELAR, RANGE ROVER SPORT, DISCOVERY, DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23110·2023-02-02

    Children's Robes Recalled for Flammability Standards Violation

    About 2,000 children's polyester robes imported by BTPEIHTD and sold on Amazon fail to meet federal flammability standards for sleepwear, posing a burn injury risk. Consumers should stop use immediately and contact the importer for a refund.

    Product
    Children's robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V043000·2023-02-02

    2023 GMC Acadia: Right-front half-shaft separation from transmission risk

    General Motors is recalling certain 2023 GMC Acadia vehicles because right-front half-shaft assemblies may separate from the transmission, potentially causing loss of drive power or vehicle rollaway and increasing crash risk.

    Product
    CADILLAC — CADILLAC, GMC XT5, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V046000·2023-02-02

    2020 Honda Fit rearview camera may not display on startup

    The rearview camera display may not activate when a 2020 Honda Fit is started with a key due to a display power circuit design error, reducing rear visibility and increasing crash risk. Dealers will provide a free software fix.

    Product
    HONDA — HONDA FIT, HR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V045000·2023-02-02

    2023 Jaguar F-Pace Engine Oil Leak Poses Fire Risk

    Jaguar is recalling 2023 F-Pace vehicles because the engine cam carrier oil channel may become blocked, causing an oil leak that could increase the risk of fire. Dealers will inspect and replace the affected engine components at no cost.

    Product
    JAGUAR — JAGUAR F-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V048000·2023-02-02

    Incorrect defroster instructions in Nissan LEAF owner's manuals increase crash risk

    Nissan is recalling 2018-2023 LEAF vehicles because the Owner's Manual has incorrect defroster operation instructions, which may reduce visibility and increase crash risk. Nissan will mail updated instructions at no charge.

    Product
    NISSAN — NISSAN LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23111·2023-02-02

    Children's Robes Recalled for Flammability Standard Violation and Burn Hazard

    Betusline Official Apparel children's robes fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 350 units sold on Amazon.com from January through April 2022 are affected.

    Product
    Children's Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23112·2023-02-02

    Children's Robes Recalled for Flammability Standards Violation

    ChildLikeMe children's robes sold on Amazon from January through April 2022 fail to meet federal flammability standards for sleepwear, posing a burn injury risk. Consumers should stop use immediately and contact the importer for a refund.

    Product
    Children's robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23113·2023-02-02

    Children's Robes Recalled for Flammability Standards Violation and Burn Hazard

    About 3,000 SGMWVB brand children's robes sold on Amazon fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk. Consumers should immediately stop using them and contact the manufacturer for a refund.

    Product
    Children's Robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V041000·2023-02-02

    2021 Toyota RAV4 Prime Engine Stall in Cold Weather Driving

    Toyota is recalling certain 2021 RAV4 Prime vehicles due to a software defect that may cause engine stall during cold-weather driving. Dealers will provide a free software update.

    Product
    TOYOTA — TOYOTA RAV4 PRIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0184-2023·2023-02-01

    Vancomycin Hydrochloride Injection Recalled for Glass Particulate Matter

    Pfizer recalls approximately 89,700 vials of Vancomycin Hydrochloride for Injection due to glass particulate matter contamination. The recalled product (Lot 33045BA) was distributed across the USA and Puerto Rico.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2023·2023-02-01

    Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation

    The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.

    Product
    Getinge Flow-c Anesthesia System, Part No. 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E005000·2023-02-01

    Navico Group Recalls RELiON InSight 48V Lithium-Ion Batteries

    Navico Group is recalling RELiON InSight 48V lithium-ion batteries because improperly formed capacitors may cause internal leaks and short circuits, increasing the risk of fire.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2023·2023-02-01

    Advil Liqui Gels Minis Recalled for Illegible Label Due to Adhesive Migration

    Glaxosmithkline Consumer Healthcare is recalling Advil Liqui Gels (minis) 200mg capsules nationwide due to illegible labeling caused by adhesive migration. Consumers should discard affected product or return it to the retailer.

    Product
    Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2023·2023-02-01

    Advil Liqui Gels Recalled Due to Illegible Labeling Defect

    Advil Liqui Gels (200mg ibuprofen capsules) are being recalled nationwide because adhesive on the packaging migrated onto the label, causing it to tear and become illegible when peeled back.

    Product
    Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2023·2023-02-01

    Epinephrine Active Pharmaceutical Ingredient Recalled for Discoloration

    Spectrum Laboratory Products is recalling Epinephrine API lot 1KG0865 due to discoloration that may compromise product effectiveness. The product was distributed nationwide in the USA, Puerto Rico, and Canada.

    Product
    Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0311-2023·2023-02-01

    Parsley from Mexico recalled due to Salmonella contamination

    FreshPoint South Florida, Inc. is recalling FC Parsley Curly Chopped Fine imported from Mexico due to Salmonella contamination. Approximately 1,269 cases were distributed in Florida.

    Product
    FC Parsley Curly Chopped Fine,12 Count, 2 1.5 Refrigerated at 34F, 301193, UPC 10022363, Parsley 12 CT, DIST BY FPSF, 22363 LOC 51, Parsley 6 CT, DIST BY FPSF, 22363 LOC 51
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0959-2023·2023-02-01

    Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect

    Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.

    Product
    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0310-2023·2023-02-01

    Parsley bunches from Mexico recalled due to Salmonella contamination

    Church Brothers, LLC is recalling parsley bunches distributed to Louisiana, Florida, and Michigan due to Salmonella contamination found in the product.

    Product
    Parsley bunches Boxes of 30 and 60 count Keep refrigerated SKU 475987 PLU 4899 on twist ties Product of Mexico
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0181-2023·2023-02-01

    Advil Ibuprofen Tablets Recalled for Illegible Labels

    Glaxosmithkline Consumer Healthcare is recalling Advil ibuprofen 200 mg tablets because adhesive migrated onto labels, causing them to tear when peeled. This affects 321,246 tablets distributed nationwide.

    Product
    Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940
    Category
    Drug
    Distribution
    Distributed nationwide

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