The Recall Desk

Archive

November 2022 recalls

456 recalls were announced in November 2022.

What the numbers show

Critical
8
Severe
101
High
296
Moderate
47
Low
4

Of the 456 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.

Which agencies issued them

1–100 of 456

  • CriticalFDA (Food)·F-0169-2023·2022-11-30

    Tiramisu Twist Cookies recalled for undeclared tree nuts

    DAISO CALIFORNIA WAREHOUSE is recalling Tiramisu Twist Cookie 3.4 oz. packages due to undeclared tree nuts. Consumers with tree nut allergies face allergic reaction risk if they consume this product unknowingly.

    Product
    Tiramisu Twist Cookie 3.4 oz. packaged in a gold bag with a large image of two cookies on the package. SKU 4562138450820 3.4 oz. packages, 12 units per case Product of Malaysia
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0174-2023·2022-11-30

    Umami Everyday Sauce recalled for undeclared soy allergen

    Umami Everyday Sauce is being recalled due to undeclared soy allergen. This poses a risk to consumers with soy allergies and sensitivities.

    Product
    Umami Everyday Sauce, 5 fl. oz. (148 mL) glass bottle, UPC 8-67732-00032-2, Made for Seed Ranch Flavor Co., LLC, Boulder, CO 80302 Ambient storage - minimum 35 degrees, maximum 85 degrees.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0176-2023·2022-11-30

    Everything But The Sushi & Dumplings sauce recalled for undeclared soy

    Seed Ranch Flavor Co. is recalling Everything But The Sushi & Dumplings sauce due to undeclared soy allergen. Approximately 11,449 bottles were distributed nationwide and internationally.

    Product
    Everything But The Sushi & Dumplings, 5 fl. oz. (148 mL) glass bottle, UPC 8-60008-58851-7, Made for Seed Ranch Flavor Co., LLC Boulder, CO 80302. Ambient storage - minimum 35 degrees, maximum 85 degrees.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0175-2023·2022-11-30

    Umami Everyday Savory Spice Recalled for Undeclared Soy

    Umami Everyday Savory Spice is recalled nationwide due to undeclared soy. The product affects consumers with soy allergies and has been distributed in the US, Canada, UK, and France.

    Product
    Umami Everyday Savory Spice, 5 fl. oz. (148 mL) glass bottle, UPC 8-50000-72724-3, Co-Packed with Seed Ranch Flavor Co., Denver, CO 80216 Ambient storage - minimum 35 degrees, maximum 85 degrees.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0172-2023·2022-11-30

    Living Hydroponic Baby Romaine Lettuce Recalled Due to Salmonella Contamination Risk

    Kalera recalls Living Hydroponic Baby Romaine Lettuce (lot #001293) due to potential Salmonella contamination. The affected products comprise 211 cases of 10-pound packages distributed domestically.

    Product
    Living Hydroponic Baby Romaine Lettuce (10lbs)(04071) Kalera, Distributed by Kalera, Inc., Orlando, FL 32822 (Bulk)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0171-2023·2022-11-30

    Kalera Krunch Lettuce Recalled for Potential Salmonella Contamination

    Kalera is recalling Krunch lettuce (lots 001293 and 001294) due to potential Salmonella contamination. Consumers should dispose of affected products.

    Product
    Kalera, The cleanest lettuce in the world, Krunch lettuce, Whole head with living roots, Distributed by Kalera, Inc, Orlando FL 32822
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0261-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled due to adhesive skin injuries

    3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.

    Product
    3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0250-2023·2022-11-30

    3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries

    3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is difficult to remove without damaging the product.

    Product
    3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0256-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries

    3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.

    Product
    3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0248-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled due to adhesive defect and skin injuries

    3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0264-2023·2022-11-30

    3M Urological Drape: Adhesive Liner Removal Issues and Skin Injuries

    3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.

    Product
    3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0259-2023·2022-11-30

    3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries

    3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.

    Product
    3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0249-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage

    3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0258-2023·2022-11-30

    3M Steri-Drape Surgery Drapes Recalled for Adhesive Liner and Skin Injuries

    3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in skin injuries.

    Product
    3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0263-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recall for Adhesive Defect and Skin Injuries

    3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from the affected lots.

    Product
    3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0177-2023·2022-11-30

    Nourish Inc. Fruit Snack Pack recalled for undeclared peanut allergen

    Nourish Inc. Fruit Snack Pack SNACK ATTACK recalled for undeclared peanut allergen. 188 units distributed to 4 customers in California.

    Product
    Nourish Inc. brand Fruit Snack Pack SNACK ATTACK 6.48 oz. Apples, Medjool Dates, Blackberries, Sunflower Butter Keep refrigerated
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0237-2023·2022-11-30

    Mighty Bliss Electric Heating Pad Recalled for Burn and Shock Risk

    Whele LLC is recalling the Mighty Bliss Electric Heating Pad due to burn and shock hazards. The company has received complaints of burns, electrical shocks, and skin irritation.

    Product
    Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0254-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries

    3M is recalling surgical drapes with defective adhesive components that may cause skin injuries. The adhesive liner is difficult to remove without damaging the product, and increased skin injuries have been reported.

    Product
    3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0173-2023·2022-11-30

    Smoked Salmon Recalled Due to Possible Listeria Contamination

    Wild caught Alaskan Sockeye smoked salmon may be contaminated with Listeria monocytogenes. Seven Seas International USA LLC is recalling 540 cases distributed to 164 retail stores.

    Product
    Wild caught Alaskan Sockeye Smoked Salmon NET WT 4 OZ (113g) EXPIRATION DATE 7-11-2024 UPC: 68826715832 Origin: USA, smoked and cured in The Netherlands
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0251-2023·2022-11-30

    3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Defects and Skin Injuries

    3M is recalling Steri-Drape Large Towel Drapes (REF 1010NS) due to adhesive liner defects that may damage the product and increased reports of adhesive-related skin injuries from affected lots.

    Product
    3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0236-2023·2022-11-30

    Mighty Bliss Electric Heating Pad recalled for burn and shock hazards

    Whele LLC is recalling the Mighty Bliss Electric Heating Pad (model MB-001) due to burn and electrical shock hazards. The firm has received complaints of burns, shocks, and skin rashes from users.

    Product
    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0170-2023·2022-11-30

    Kalera Butter Lettuce Recalled for Potential Salmonella Contamination

    Kalera butter lettuce (lot #001293 and #001294) is being recalled due to potential Salmonella contamination. Consumers should not consume the affected product.

    Product
    Kalera, The cleanest lettuce in the world., Butter lettuce, Whole head with living roots, Distributed by Kalera, Inc, Orlando FL 32822
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0238-2023·2022-11-30

    Mighty Bliss Electric Heating Pad recalled due to burn and shock hazard

    Whele LLC is recalling approximately 4,034 Mighty Bliss Electric Heating Pads due to burn and shock hazards. The firm received complaints of burns, mild electrical shocks, and skin irritation.

    Product
    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0255-2023·2022-11-30

    3M Steri-Drape surgical drape recalled due to adhesive skin injuries

    3M is recalling Steri-Drape surgical drapes because the liner on the adhesive component is difficult to remove without damaging the drape. An increase in adhesive-related skin injuries has been reported for affected lots.

    Product
    3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0257-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled for adhesive liner defects and skin injuries

    3M is recalling Steri-Drape surgical drapes due to a defective adhesive liner that is difficult to remove and may render the drape unusable. Reported adhesive-related skin injuries have been linked to the affected lots.

    Product
    3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0253-2023·2022-11-30

    3M Steri-Drape surgical drape recalled for adhesive liner defect and skin injuries

    3M is recalling 769,810 Steri-Drape surgical drapes worldwide due to a defective adhesive liner that is difficult to remove and has caused reported skin injuries.

    Product
    3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0262-2023·2022-11-30

    3M Steri-Drape General Surgery Drape Recall for Adhesive Skin Injuries

    3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.

    Product
    3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0288-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to LA, MO, NC, and FL.

    Product
    regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0290-2023·2022-11-30

    Eye Surgery Convenience Kits Recalled for Containing Recalled 3M Drapes

    ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.

    Product
    regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0294-2023·2022-11-30

    Surgical Convenience Kits Recalled for Containing Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 170 surgical convenience kits containing 3M surgical drapes that were previously recalled. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0260-2023·2022-11-30

    3M Steri-Drape surgical drape recalled for adhesive skin injuries

    3M recalls specific batches of Steri-Drape surgical drapes due to reported adhesive-related skin injuries and potential product damage from difficult-to-remove adhesive liners.

    Product
    3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0279-2023·2022-11-30

    Surgical Blade Safety Cartridges Recalled Due to Missing Sterilization

    Southmedic is recalling 450 units of sterile surgical blade cartridges (Lot W92761) because the product was not sterilized but was labeled and distributed as sterile. Non-sterile surgical blades could cause infection if used on patients.

    Product
    Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0266-2023·2022-11-30

    Allison Medical recalls InControl insulin syringes for incorrect needle gauge labeling

    Allison Medical is recalling 150,000 InControl insulin syringes distributed in Texas due to incorrect package labeling of needle gauge. The mislabeled packages may lead patients to unknowingly select the wrong needle size.

    Product
    InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0274-2023·2022-11-30

    Basin Set Medical Device Kit Contents Do Not Match Label

    American Contract Systems, Inc. is recalling a surgical basin set (MEBS42K) because the kit contents do not match the labeled contents. The mismatch could result in improper surgical preparation.

    Product
    BASIN SET, MEBS42K, general surgical kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2023·2022-11-30

    Surgical kits recalled: Regard VITRECTOMY PK contained 3M recalled components

    Regard VITRECTOMY PK surgical convenience kits are being recalled because they contain 3M surgical drapes that were separately recalled. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighUSDA FSIS·PHA-11302022-01·2022-11-30

    USDA Issues Public Health Alert for Summer Sausage Due to Plastic Contamination

    USDA issued a public health alert for fully cooked summer sausage products from Paradise Locker Meats due to possible plastic contamination. No illnesses have been reported.

    Product
    Paradise Locker Meats — FSIS Issues Public Health Alert for Fully Cooked Summer Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled 3M drapes

    Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0304-2023·2022-11-30

    Hip Arthroplasty Surgical Convenience Kits Recalled Due to Defective 3M Drapes

    ROi CPS LLC is recalling regard TOTAL HIP ARTHROPLASTY surgical convenience kits containing recalled 3M surgical drapes distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0300-2023·2022-11-30

    Regard Retinal Pack surgical kits recalled for defective 3M drapes

    ROi CPS LLC is recalling Regard Retinal Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained recalled 3M surgical drapes.

    Product
    regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0252-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recalled for Adhesive Liner Defect and Skin Injuries

    3M is recalling 84,000 units of Steri-Drape surgical drapes because the adhesive component's liner is difficult to remove without damaging the product, and there have been reported adhesive-related skin injuries.

    Product
    3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0311-2023·2022-11-30

    Neuro surgery kits recalled for defective 3M surgical drapes

    ROi CPS LLC is recalling 790 neuro surgery convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0319-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Included 3M Surgical Drapes

    ROi CPS LLC is recalling 54 regard LATERAL SHOULDER surgical convenience kits containing 3M surgical drapes that were subsequently recalled by the manufacturer. Affected kits were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0293-2023·2022-11-30

    Surgical convenience kits recalled due to defective surgical drapes

    Regard MAJOR EAR surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida are being recalled because the kits contained 3M surgical drapes that were subsequently recalled.

    Product
    regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0321-2023·2022-11-30

    Regard SPINE Surgical Kits Recalled for Containing Unsafe Drapes

    ROi CPS LLC is recalling 302 Regard SPINE surgical convenience kits containing 3M surgical drapes that were subject to an FDA recall. Affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0322-2023·2022-11-30

    Shoulder arthroscopy surgical convenience kits recalled due to defective 3M drapes

    ROi CPS LLC is recalling 90 regard shoulder arthroscopy surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0312-2023·2022-11-30

    Neurosurgery convenience kits recalled due to included recalled surgical drapes

    ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.

    Product
    regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0318-2023·2022-11-30

    Regard Shoulder surgical kits recalled due to defective included drapes

    ROi CPS LLC is recalling Regard SHOULDER surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. Affected kits were distributed to healthcare facilities in LA, MO, NC, and FL.

    Product
    regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0285-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Included Recalled Surgical Drapes

    ROi CPS LLC is recalling 326 regard TOTAL JOINT surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that were previously recalled. No illnesses or injuries have been reported.

    Product
    regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0298-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled Surgical Drapes

    Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0265-2023·2022-11-30

    B. Braun Central Venous Catheter Tray Recalled for Incorrect Expiration Date Label

    Medical Action Industries is recalling 240 cases of B. Braun CARESITE Port Access Kits (REF 375214) due to incorrect expiration date labeling. The kits show an expiration date of 02/21/2024 when the actual expiration is 02/10/2024.

    Product
    B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2023·2022-11-30

    PAJUNK Continuous Epidural Tray Recalled for Wrong Medication in Kit

    Pajunk Medical Systems is recalling PAJUNK Continuous Epidural Trays (Model TAL101, Lot 0001359) because some contain 0.75% Marcaine Spinal instead of the intended 0.9% Sodium Chloride. This medication substitution could lead to improper drug administration during epidural procedures.

    Product
    PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2023·2022-11-30

    Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

    Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

    Product
    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0273-2023·2022-11-30

    Knee Prosthesis Devices Recalled for Potential Sterility Packaging Issue

    Corin Ltd is recalling the Unity Total Knee System due to potential damage to internal packaging that could compromise device sterility. No injuries have been reported.

    Product
    Unity Total Knee System. Used for knee prosthesis in total knee replacement
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0168-2023·2022-11-30

    Tomato Head Black Bean Sriracha Hummus Recalled for Potential Metal Fragments

    Tomato Head Foods is recalling Tomato Head Black Bean Sriracha Hummus packaged in 8oz cups due to potential metal fragments in the product.

    Product
    The Tomato Head Black Bean Sriracha Hummus packaged in 8oz PPE plastic cups - 8 cups per case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0272-2023·2022-11-30

    Medfusion 4000 Syringe Pump May Delay Sending EHR Infusion Start Messages

    Smiths Medical's Medfusion 4000 infusion pump software may delay sending infusion start messages to Electronic Health Record systems, potentially affecting infusion programming and clinical documentation.

    Product
    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0267-2023·2022-11-30

    Ventilator Screen Backlight Malfunction Causes Temporary Display Loss

    Hamilton-C6 ventilators are subject to a backlight malfunction causing the display screen to go black for 2-3 seconds. The FDA has classified this Class II recall as affecting 443 U.S. systems distributed nationwide.

    Product
    Hamilton-C6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2023·2022-11-30

    Regard LAMINECTOMY surgical kits recalled due to recalled 3M drapes

    ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0282-2023·2022-11-30

    VS3 Iridium Visionsense Beam Combiner Optical Fiber Cable Damage Risk

    Visionsense VS3 Iridium beam combiners may develop damaged optical fiber cables through handling or bending, causing loss of functionality and potential cable heating or melting. Affected units were distributed nationwide in the US.

    Product
    VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Included 3M Surgical Drapes

    Surgical convenience kits are being recalled because they contained 3M surgical drapes that were subsequently recalled. 177 kits distributed in Louisiana, Missouri, North Carolina, and Florida are affected.

    Product
    regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0280-2023·2022-11-30

    Visionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage

    Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.

    Product
    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0166-2023·2022-11-30

    G FUEL Watermelon Limeade Energy Drink recalled for incorrect caffeine labeling

    G FUEL LLC is recalling 48,000 units of GFUEL brand Watermelon Limeade Energy Drink nationwide because the product label does not declare the correct amount of caffeine.

    Product
    GFUEL brand Watermelon Limeade Energy Drink; 16 fl. oz.; ready-to-drink energy beverage in a can
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2023·2022-11-30

    3M Steri-Drape surgical drape with defective adhesive liner recalled

    3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0308-2023·2022-11-30

    Surgical convenience kits recalled for defective 3M drape components

    ROi CPS LLC recalls 213 surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The affected kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0292-2023·2022-11-30

    Neurosurgery Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.

    Product
    regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0302-2023·2022-11-30

    Surgical Convenience Kits with Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0167-2023·2022-11-30

    Tomato Head Beet Hummus Recalled for Potential Metal Fragments

    Tomato Head Foods is recalling Tomato Head Beet Hummus in 8oz cups due to potential metal fragments in the product. The recalled product was distributed to distribution centers in California, Florida, Georgia, and Illinois.

    Product
    The Tomato Head Beet Hummus packaged in 8oz PPE plastic cups - 8 cups per case
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0303-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

    ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.

    Product
    ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0289-2023·2022-11-30

    Surgical convenience kits recalled due to included 3M surgical drapes

    Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0295-2023·2022-11-30

    Recall of Surgical Convenience Kits Containing Recalled 3M Drapes

    ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0305-2023·2022-11-30

    Surgical Convenience Kits Recalled by ROi CPS Due to Included 3M Surgical Drapes

    ROi CPS LLC is recalling 456 surgical convenience kits containing 3M surgical drapes that were subject to a separate recall. The kits were distributed across Louisiana, Missouri, North Carolina, and Florida.

    Product
    ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0316-2023·2022-11-30

    Eye Surgery Convenience Kits Recalled for Defective Surgical Drapes

    Cataract eye surgery convenience kits containing recalled 3M surgical drapes were distributed to four states. ROi CPS LLC has recalled 780 units of the regard CATARACT product.

    Product
    regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0269-2023·2022-11-30

    MicroScan autoSCAN-4 Instrument Recall Due to Incorrect Diffuser Plate

    Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.

    Product
    MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0286-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Unsafe 3M Surgical Drapes

    ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0281-2023·2022-11-30

    Medical device recall: VS3 Iridium infrared fluorescence microscope

    Visionsense, Ltd. issued a voluntary Class II recall of the VS3 Iridium infrared fluorescence microscope affecting 34 units with US Nationwide distribution.

    Product
    VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Included 3M Drape Components

    Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.

    Product
    regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0310-2023·2022-11-30

    Surgical Convenience Kits Recalled for Included 3M Surgical Drapes

    ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.

    Product
    regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0299-2023·2022-11-30

    Surgical convenience kits containing recalled 3M surgical drapes

    ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.

    Product
    regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0287-2023·2022-11-30

    Surgical convenience kits recalled for containing 3M surgical drapes

    ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.

    Product
    regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0068-2023·2022-11-30

    Pantoprazole Sodium Oral Suspension Recalled for Discoloration

    Sun Pharmaceutical recalls Pantoprazole Sodium oral suspension nationwide due to product discoloration. Lot MHC1317A with approximately 14,064 units was distributed in the USA.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2023·2022-11-30

    Surgical Convenience Kits Containing Recalled 3M Surgical Drapes

    Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.

    Product
    ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0315-2023·2022-11-30

    Eye Surgery Kit Recall Due to Defective Surgical Drapes

    ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.

    Product
    regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0284-2023·2022-11-30

    Surgical convenience kits recalled for containing recalled 3M drapes

    Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.

    Product
    regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0317-2023·2022-11-30

    Surgical Urology Kits Recalled Due to Defective 3M Drapes

    ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.

    Product
    regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0297-2023·2022-11-30

    FDA Class II Recall of Surgical Convenience Kits with Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.

    Product
    regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0307-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.

    Product
    regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2023·2022-11-30

    Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes

    ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.

    Product
    regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0313-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective Component Drapes

    ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.

    Product
    regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0314-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled drape components

    Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).

    Product
    regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-0069-2023·2022-11-30

    Phenytoin Sodium Injection Recalled for Missing Barcode on Vial Label

    Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.

    Product
    PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0070-2023·2022-11-30

    Phenytoin Sodium Injection Recalled for Missing Vial Barcode

    Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.

    Product
    PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E097000·2022-11-29

    MW Company Recalls WELD Off-Road Wheels Due to Cracking Risk

    MW Company LLC is recalling specific WELD off-road wheels that may crack and separate from the rim, increasing the risk of a crash.

    Product
    WHEELS:LUGS/NUTS/BOLTS/STUDS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V879000·2022-11-29

    Spartan Fire Metro Star and FC-94 Trucks Recalled for Steering Defect

    Alexis Fire Equipment is recalling 2021-2023 Spartan Metro Star and FC-94 fire trucks because improperly heat-treated tie rod clamps may fail, causing loss of steering.

    Product
    SPARTAN FIRE — SPARTAN FIRE METROSTAR, FC-94
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V882000·2022-11-29

    Travel trailer LP gas fittings may crack and leak, risking fire

    Holiday House is recalling 2021–2022 travel trailers because the quick disconnect fittings in the LP gas system may be cracked, causing gas leaks that could lead to fires. Owners should contact Holiday House for inspection and free replacement.

    Product
    HOLIDAY HOUSE — HOLIDAY HOUSE 18RB, 27RQ, 24TB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V884000·2022-11-29

    Winnebago travel trailers recalled for incorrect cargo capacity labels

    Winnebago is recalling certain 2021-2022 Minnie and Voyage travel trailers due to incorrect cargo carrying capacity labels, which could lead to vehicle overloading and loss of control.

    Product
    WINNEBAGO — WINNEBAGO MINNIE, VOYAGE!
    Category
    Vehicle
    Distribution
    Distributed nationwide

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