The Recall Desk

Archive

March 2022 recalls

662 recalls were announced in March 2022.

What the numbers show

Critical
25
Severe
167
High
312
Moderate
150
Low
8

Of the 662 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.

Which agencies issued them

301–400 of 662

  • SevereFDA (Food)·F-0954-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Pathogenic Bacterial Contamination

    Abbott is recalling Similac Alimentum infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport bacteria. The bacteria were found in some products and in the manufacturing facility.

    Product
    Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0955-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott Laboratories is recalling 45,223 cases of Similac Alimentum infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and evidence of Cronobacter sakazakii in the manufacturing facility.

    Product
    Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0944-2022·2022-03-16

    Abbott Similac Organic infant formula recalled for pathogenic bacteria contamination

    Abbott is recalling Similac Organic infant formula due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects roughly 8514 cases distributed nationwide and internationally.

    Product
    Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. Item numbers: 67905 68104 Retail UPCs: 070074677576 070074681054
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0921-2022·2022-03-16

    Abbott Similac Total Comfort Infant Formula Recalled for Pathogen Contamination

    Abbott Similac Total Comfort infant formula is recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport, following consumer complaints in infants and evidence of the pathogen in the manufacturing facility.

    Product
    Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0939-2022·2022-03-16

    Abbott Similac Total Comfort Infant Formula Recalled for Cronobacter and Salmonella

    Abbott Similac Total Comfort Infant Formula with Iron is being recalled due to consumer complaints related to Cronobacter sakazakii and Salmonella Newport. The FDA classified this Class I recall affecting over 1.2 million cases.

    Product
    Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0826-2022·2022-03-16

    Fresh Enoki Mushrooms Recalled Due to Listeria Contamination

    Concord Farms is recalling Fresh Enoki Mushrooms due to Listeria monocytogenes contamination found by the California Department of Public Health. The affected product was distributed in California and Nevada.

    Product
    Fresh Enoki Mushrooms 5.25oz/150 g/ 34 packages per case UPC: 001958939091 Distributed by Concord Farms, Vernon, CA Do not eat raw.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0918-2022·2022-03-16

    Abbott EleCare Infant Formula Batch 26811Z200 Recalled for Pathogen Contamination

    Abbott Laboratories is recalling Batch 26811Z200 of Abbott EleCare Infant Formula Unflavoured due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants.

    Product
    Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0827-2022·2022-03-16

    Taiwan Best Quality Enoki Mushrooms Recalled for Listeria Contamination

    Jan Fruits, Inc. is recalling Taiwan Best Quality Enoki Natural Mushrooms due to Listeria monocytogenes contamination found by California Department of Public Health. Approximately 617 cases were distributed in California.

    Product
    Taiwan Best Quality Enoki Natural Mushrooms, Premium 200g/7.5 oz. clear plastic package. 50 pcs per box. Manufacturer: Changhua County Mushroom Production Cooperative; Distributed by Jan Fruits. UPC: 8 51084 00835 8
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0949-2022·2022-03-16

    Abbott EleCare Infant Formula Recalled for Potential Cronobacter and Salmonella

    Abbott Laboratories is recalling EleCare infant formula nationwide and worldwide due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens have been received involving infants.

    Product
    Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55251 5525157 5525189 Retail UPCs: 070074535111 070074116297 070074119854
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0942-2022·2022-03-16

    Abbott Similac Alimentum infant formula recalled for Cronobacter and Salmonella

    Abbott Laboratories is recalling Similac Alimentum infant formula due to contamination with Cronobacter sakazakii and Salmonella Newport. The recall involves 34,704 cases distributed nationwide and worldwide following consumer complaints and manufacturing facility testing.

    Product
    Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0948-2022·2022-03-16

    Abbott infant formula recalled due to bacterial contamination

    Abbott Laboratories is recalling EleCare and Similac EleCare infant formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport infections in infants, and Cronobacter contamination in the manufacturing facility.

    Product
    Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0946-2022·2022-03-16

    Abbott Similac Organic Infant Formula recalled for Cronobacter and Salmonella

    Abbott Similac Organic with A2 Milk Infant Formula is being recalled following consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants, plus evidence of Cronobacter in the manufacturing facility.

    Product
    Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4 jars per case. Item numbers: 67904 68016 68099 Retail UPCs: 070074677545 070074680170 070074681009
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2022·2022-03-16

    Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure

    American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0695-2022·2022-03-16

    Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment

    The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0717-2022·2022-03-16

    Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.

    Product
    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2022·2022-03-16

    LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.

    Product
    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0718-2022·2022-03-16

    FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization

    Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.

    Product
    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0935-2022·2022-03-16

    Abbott Similac infant formula recalled due to bacterial contamination

    Abbott is recalling multiple Similac infant formula products due to potential contamination with Cronobacter sakazakii and Salmonella Newport. These pathogens pose serious health risks to infants.

    Product
    Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 07007468
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0923-2022·2022-03-16

    Abbott Similac For Spit Up Infant Formula recalled for pathogenic bacterial contamination

    Abbott Laboratories is recalling Similac For Spit Up Infant Formula nationwide and worldwide due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The pathogens were identified through consumer complaints and detected in the manufacturing facility.

    Product
    Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0919-2022·2022-03-16

    Abbott Similac Human Milk Fortifier Recalled Due to Pathogen Risk

    Abbott Similac Human Milk Fortifier pouches are recalled due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects infants who may have received contaminated product.

    Product
    Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 07007467
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0947-2022·2022-03-16

    Abbott Similac 360 Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive Infant Formula due to potential Cronobacter sakazakii or Salmonella Newport contamination. The recall affects products distributed in the United States and worldwide.

    Product
    Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item numbers: 68070 68072 68118 Retail UPCs: 070074680712 070074680736 070074681191
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0953-2022·2022-03-16

    Abbott EleCare Jr Nutrition Powder Recalled Due to Bacterial Contamination

    Abbott is recalling EleCare Jr Amino Acid-Based Nutrition Powder due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants. The bacteria was also found in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0943-2022·2022-03-16

    Abbott Similac 360 Infant Formula recalled for Cronobacter and Salmonella

    Abbott is recalling Similac 360 Total Care Infant Formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants, with Cronobacter found in the manufacturing facility.

    Product
    Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0952-2022·2022-03-16

    Abbott EleCare Jr Amino Acid Powder Recalled for Pathogenic Bacteria

    Abbott EleCare Jr Amino Acid-Based Nutrition Powder (banana) is recalled due to consumer complaints of Cronobacter sakazakii or Salmonella Newport in infants, with pathogen evidence in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0957-2022·2022-03-16

    Abbott Infant Formula Powder Recalled for Bacterial Contamination

    Abbott Laboratories is recalling infant formula powder due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported.

    Product
    Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Bacterial Contamination

    Abbott Laboratories recalls Similac Alimentum Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination. Consumer complaints related to infections in infants and manufacturing facility contamination prompted the FDA Class I recall.

    Product
    Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0929-2022·2022-03-16

    Abbott Similac EleCare infant formula recalled for pathogen contamination

    Abbott is recalling approximately 95,077 cases of Similac EleCare infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and detection of Cronobacter sakazakii in the manufacturing facility.

    Product
    Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155 007007412385
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0694-2022·2022-03-16

    Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect

    ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2022·2022-03-16

    ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning

    ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.

    Product
    ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·F-0838-2022·2022-03-16

    Chicago Sweet Connections Paczkis Recall: Undeclared Egg, Milk, Wheat Allergens

    Chicago Sweet Connections is recalling Prune Flavor Paczkis (4-pack, UPC 841049024035) due to undeclared allergens: egg, milk, and wheat. Affected products were distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Paczkis - Prune Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0821-2022·2022-03-16

    La Fiesta Salted Plums with Chili Recalled for Elevated Lead Levels

    La Fiesta brand Salted Plums with Chili are being recalled due to elevated lead levels in the product. The recall affects 8,304 packages distributed across Arkansas, California, Georgia, North Carolina, Nevada, Oklahoma, and Utah.

    Product
    La Fiesta brand, Salted Plums with Chili Product. Product is packaged in cello bags, net wt. 1oz. UPC 0 32327 02829 0. There are 8 dozens per case. Product is labeled in parts: "***SALADITOS CON CHILE *** SALTED PLUMS WITH CHILI ***PRODUCT OF CHINA***Distributed By: La Fiesta F
    Category
    Food
    Distribution
    7 states
  • HighCPSC·22100·2022-03-16

    Specialized Bicycle Crank Arm Disengagement Recall Poses Fall Hazard

    Specialized is recalling about 19,000 Sirrus bicycles with defective alloy cranks that can disengage and cause falls. The manufacturer has received 30 reports of the defect, but no injuries have been reported.

    Product
    Sirrus, Sirrus X and Sirrus Sport Bicycles with alloy cranks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22103·2022-03-16

    B. toys Wooden Activity Walker recalled for choking hazard

    B. toys Walk 'n' Learn wooden toddler walkers are being recalled because wheels and attachment hardware can detach in small pieces, creating a choking hazard for young children. Battat has received six reports of detachment, including one incident where a child placed a detached metal nut in her mouth.

    Product
    B. toys Wooden Activity Walker - Walk 'n' Learn
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V160000·2022-03-16

    Harley-Davidson Motorcycles Recalled for Detaching Brake Fluid Warning Labels

    Harley-Davidson is recalling certain 2021-2022 XL Sportster motorcycles because brake fluid warning labels may detach from reservoir caps. Missing labels could lead to improper brake maintenance and increased crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XL883N, XL1200X, XL1200NS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0840-2022·2022-03-16

    Chicago Sweet Connections Paczkis Recalled for Undeclared Allergens

    Chicago Sweet Connections is recalling Strawberry Flavor Paczkis (4-pack) because the product contains undeclared allergens: egg, milk, and wheat. Products were distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Paczkis - Strawberry Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0837-2022·2022-03-16

    Pineapple Paczkis recalled for undeclared egg, milk, and wheat allergens

    Chicago Sweet Connections is recalling Pineapple Flavor Paczkis due to undeclared allergens: egg, milk, and wheat. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Paczkis - Pineapple Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0844-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Recalled for Undeclared Allergens

    Chicago Sweet Connections is recalling its Coffee Cake - Cheese Flavor due to undeclared allergens: egg, milk, and wheat. The product was distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Cheese Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighCPSC·22099·2022-03-16

    Reckitt Recalls 3.74 Million Bottles of Airborne Gummies for Pressure Hazard

    RB Health (Reckitt) is recalling approximately 3.74 million bottles of Airborne Gummies (63 and 75 count) because pressure buildup can cause the cap and seal to pop off with force upon first opening, posing an injury hazard.

    Product
    Airborne Gummies (63 and 75 count bottles)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V163000·2022-03-16

    2022 Volkswagen Golf R engine design cover fire risk recall

    The engine design cover in 2022 Volkswagen Golf R vehicles may loosen during high acceleration and contact hot engine surfaces, increasing fire risk. Dealers will remove it free of charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R, GTI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0836-2022·2022-03-16

    Chicago Sweet Connections chocolate paczkis recalled for undeclared allergens: egg, milk, wheat

    Chicago Sweet Connections is recalling chocolate paczkis sold in Illinois and Wisconsin due to undeclared egg, milk, and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Paczkis - Chocolate Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0834-2022·2022-03-16

    Chicago Sweet Connections Paczkis Recalled Due to Undeclared Allergens

    Chicago Sweet Connections is recalling Cheese Flavor Paczkis due to undeclared allergens: egg, milk, and wheat. The product was distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Paczkis - Cheese Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0839-2022·2022-03-16

    Chicago Sweet Connections Paczkis recalled due to undeclared egg, milk, and wheat allergens

    Chicago Sweet Connections Paczkis (Raspberry Flavor) are recalled because they contain undeclared egg, milk, and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Paczkis - Raspberry Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0820-2022·2022-03-16

    Pineapple Rum Cake Recalled for Undeclared Allergens: Eggs, Wheat, Milk

    Edible Spirits, Inc. is recalling Pineapple Rum Cake because the product labels fail to declare eggs, wheat, and milk. Consumers with allergies to these ingredients should not consume this product.

    Product
    Pineapple Rum Cake
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0851-2022·2022-03-16

    Del Monte Bubble Fruit cups recalled for potential metal fragments

    DEL MONTE FOODS INC is recalling Del Monte Bubble Fruit Tropical Mixed Fruit Cup Snacks due to potential metal fragments approximately 2–3 mm in size. No injuries have been reported.

    Product
    Del Monte Bubble Fruit - Tropical Mixed Fruit Cup Snacks. Mixed fruit and popping boba with sweetened juice. 3.5 0z (4 pack), 6 x 4 pack sleeves per carton UPC: 24000 25236
    Category
    Food
    Distribution
    29 states
  • HighFDA (Food)·F-0853-2022·2022-03-16

    Nature's Eats Nut for Life Balance Mix recalled for undeclared milk

    Texas Star Nut and Food Co. is recalling Nature's Eats Nut for Life Balance Mix 12 oz. because it contains undeclared milk, a common allergen. Approximately 836 cases were distributed to 21 states.

    Product
    Nature's Eats Nut for Life Balance Mix 12 oz. UPC 832112003996 packaged in clamshell tub 12 tubs to a case
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0818-2022·2022-03-16

    Margarita Splash cakes recalled due to undeclared allergens

    Edible Spirits, Inc. is recalling Margarita Splash cakes because the product fails to declare ingredients including common allergens: eggs, wheat, milk, and tree nuts.

    Product
    Margarita Splash
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0842-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Recalled for Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections is recalling Apricot Flavor Coffee Cake due to undeclared allergens (egg, milk, and wheat) on the label. The product was distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Apricot Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0741-2022·2022-03-16

    FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results

    Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.

    Product
    Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2022·2022-03-16

    PCA 4000 Dental Curing Units May Not Fully Cure Resins

    Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).

    Product
    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2022·2022-03-16

    Philips X-ray System Cooling Leak Poses Fire Risk

    Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.

    Product
    Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2022·2022-03-16

    FDA Recalls Diagnostic Test Strips for False Positive Results

    NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.

    Product
    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2022·2022-03-16

    Proton Therapy Systems May Fail to Verify Beam Range After Pause

    Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.

    Product
    ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0743-2022·2022-03-16

    Medtronic endotracheal tubes recalled due to manufacturing nonconformity

    Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.

    Product
    NIM TRIVANTAGE EMG Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2022·2022-03-16

    Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications

    A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.

    Product
    HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0828-2022·2022-03-16

    Dried Salted Plums Recalled for Elevated Lead Levels

    Pacific Golden Coast Trading Inc is recalling 820 cases of dried salted plums due to elevated lead levels. The product was distributed in California and Texas.

    Product
    Dried salted plum, packaged in 22 lbs. carton. Product of China.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0735-2022·2022-03-16

    Laboratory diagnostic tips recalled for potential dispensing errors

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.

    Product
    VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2022·2022-03-16

    Philips Allura Xper X-ray systems cooling system leak poses fire risk

    Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.

    Product
    Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2022·2022-03-16

    Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect

    Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.

    Product
    1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0831-2022·2022-03-16

    Paczkis recalled for undeclared egg, milk, and wheat allergens

    Chicago Sweet Connections is recalling its Apple Flavor Paczkis due to undeclared egg, milk, and wheat allergens. Consumers with sensitivities to these allergens should not consume the product.

    Product
    Chicago Sweet Connections: Paczkis - Apple Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0722-2022·2022-03-16

    Diagnostic Testing Plates Recalled for Inaccurate Antibiotic Susceptibility Results

    Remel Inc is recalling 1210 Thermo Sensititre Gram Negative Testing Plates due to inaccurate susceptibility results that could affect antibiotic resistance testing.

    Product
    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0739-2022·2022-03-16

    Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect

    Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2022·2022-03-16

    Radiation therapy planning software displays wrong images during animation playback

    RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.

    Product
    RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Includi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2022·2022-03-16

    Surgical hammertoe instruments recalled for potential locking mechanism deformation

    The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0817-2022·2022-03-16

    Key Lime Rum Cakes Recalled for Undeclared Allergens

    Edible Spirits, Inc is recalling Key Lime Rum cakes due to failure to declare allergens (eggs, wheat, milk, tree nuts) on the label. Consumers with these allergies risk allergic reaction.

    Product
    Key Lime Rum
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0849-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Contains Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections is recalling its Coffee Cake - Raspberry Flavor because it contains undeclared egg, milk, and wheat allergens that are not listed on the product label.

    Product
    Chicago Sweet Connections: Coffee Cake - Raspberry Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0822-2022·2022-03-16

    El Chavito Saladitos Dried Salted Plums Recalled for Potential Lead Contamination

    El Chavito Saladitos Dried Salted Plums are being recalled due to potential lead contamination. The recall affects 37,552 packages distributed nationwide.

    Product
    El Chavito¿ Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 859470006049, Master Case UPC 859470006629. El Chavito¿ Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 850013297221, Master Case UPC 850013297726.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2022·2022-03-16

    Chicago Sweet Connections paczkis recalled for undeclared egg, milk, wheat allergens

    Chicago Sweet Connections is recalling blueberry paczkis due to undeclared egg, milk, and wheat allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Paczkis - Blueberry Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0816-2022·2022-03-16

    Banana Coconut Rum Cake Recalled for Undeclared Allergens

    Edible Spirits, Inc is recalling Banana Coconut Rum Cake because the product was not labeled with required allergen information including eggs, wheat, milk, and tree nuts.

    Product
    Banana Coconut Rum Cake
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0856-2022·2022-03-16

    Dry Salted Plum with Chili Products Recalled for Potential Lead Contamination

    El Super Leon and El Leoncito brand Dry Salted Plum with Chili products are recalled due to potential lead contamination. Consumers should not consume these products.

    Product
    El Super Leon brand, Dry Salted Plum with Chili, Shelf Stable, packaged in plastic bag, Net Wt 1.05oz, UPC 8-52605-00408. With 12 packs of 12 units per case, for a total of 144 units per case. El Leoncito brand, Dry Salted Plum with Chili, Shelf Stable, packaged in plastic bag,
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0846-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Recalled for Undeclared Allergens

    Chicago Sweet Connections coffee cake in chocolate chip flavor is being recalled due to undeclared egg, milk, and wheat allergens. The product was distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Chocolate Chip Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0835-2022·2022-03-16

    Chicago Sweet Connections Paczkis recalled for undeclared allergens

    Chicago Sweet Connections: Paczkis - Cherry Flavor 4-packs contain undeclared egg, milk, and wheat allergens. Consumers with allergies should not consume this product.

    Product
    Chicago Sweet Connections: Paczkis - Cherry Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0819-2022·2022-03-16

    Rum in Your Face Cakes Recalled for Undeclared Allergens

    Edible Spirits, Inc recalls Rum in Your Face cakes due to failure to declare allergens on the label, including eggs, wheat, milk, and tree nuts. Consumers with allergies to these ingredients should not consume this product.

    Product
    Rum in Your Face
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0854-2022·2022-03-16

    Coca-Cola Cherry Zero Sugar Recalls Cans Missing PKU Warning Label

    Coca-Cola Cherry Zero Sugar 12-packs distributed in AZ, UT, and WY are being recalled because individual cans lack required phenylketonuric (PKU) warning labels, which are necessary for people with phenylketonuria.

    Product
    Coca-Cola Cherry Zero Sugar Fridge Pack, 12 - 12 FL OZ CANS (144 FL OZ) in a 12-pack fridge pack carton. UPC 049000047516; UPC Cherry Coca-Cola Zero Sugar can 049000047561; Cherry Coca-Cola can 04905004. There are 2 12-packs per case.
    Category
    Food
    Distribution
    3 states
  • HighCPSC·22102·2022-03-16

    RH Illuminated Mirrors Recalled Due to Fire and Shock Hazards

    RH is recalling about 3,300 illuminated mirrors sold from September 2015 through February 2022 due to loose components in bulb sockets that can cause overcurrent, overheating, fire, and electrical shock. Consumers should stop using them immediately and contact RH for a refund or replacement.

    Product
    Illuminated Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0845-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Recall Due to Undeclared Allergens

    Chicago Sweet Connections is recalling Coffee Cake - Cherry Flavor due to undeclared allergens (egg, milk, and wheat). Affected products were distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Cherry Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0855-2022·2022-03-16

    Dry Salted Plums Recalled Due to Potential Lead Contamination

    El Super Leon Ponchin Snacks is recalling EL Leoncito and El Super Leon brand dry salted plums due to potential lead contamination. Consumers should not consume these products.

    Product
    EL Leoncito brand Dry Salted Plum, Shelf Stable, packaged in plastic bag, Net Wt 1.4oz, UPC 8-52605-00024. 12 packs with 12 units per case - 144 total units El Super Leon brand Dry Salted Plum, Shelf Stable, packaged in plastic bag, Net Wt 1.4oz, UPC 8-52605-00407. The label i
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0847-2022·2022-03-16

    Coffee Cake with Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections is recalling Coffee Cake - Custard Flavor due to undeclared allergens: egg, milk, and wheat. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Coffee Cake - Custard Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0832-2022·2022-03-16

    Chicago Sweet Connections Paczkis Recalled for Undeclared Egg, Milk, Wheat

    Chicago Sweet Connections is recalling Apricot Flavor Paczkis due to undeclared allergens (egg, milk, wheat). Consumers with allergies should not consume this product.

    Product
    Chicago Sweet Connections: Paczkis - Apricot Flavor packaged in a clear plastic clamshell 4 pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0848-2022·2022-03-16

    Pecan Coffee Cake Recalled for Undeclared Allergens: Egg, Milk, Wheat

    Chicago Sweet Connections is recalling its Coffee Cake - Pecan Flavor due to undeclared allergens (egg, milk, wheat) not listed on the label. The product was distributed in Illinois and Wisconsin retail locations.

    Product
    Chicago Sweet Connections: Coffee Cake - Pecan Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0824-2022·2022-03-16

    Saladitos With Chili Recalled for Elevated Lead Levels

    A & E Corrales LLC is recalling Saladitos With Chili (16 oz) due to elevated levels of lead. The product was sold to online customers.

    Product
    Saladitos With Chili, Net Weight 16 oz (1lb) with UPC 0661799748162. The product is packaged in ultra clear sealed zip-lock plastic bag. There is no expiry date and no lot code.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0825-2022·2022-03-16

    LUPAG Dried Salted Plums Recalled for Elevated Lead Levels

    LUPAG brand Plain Dried Salted Plums are being recalled by Rojas Inc. due to elevated lead levels. Consumers should not eat this product.

    Product
    LUPAG brand Plain Dried Salted Plums, net wt. 0.5oz, pre-priced at $.99 packaged in transparent poly bags sealed with a cardboard header, stapled one dozen packages on a cardboard strip. UPC 7 25535 01133 7. Ingredients: Dried Prunes, salt. Origin: Taiwan or China Rojas Incor
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0841-2022·2022-03-16

    Coffee Cake Recalled for Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections is recalling Coffee Cake - Apple Flavor due to undeclared allergens: egg, milk, and wheat. The affected product was sold in retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Apple Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0829-2022·2022-03-16

    Factor 75 Chili Meal Recalled for Undeclared Milk Allergen

    Factor 75 Fiery Beef & Black Bean Chili meals are being recalled due to undeclared milk allergen. The product was distributed nationwide and may affect consumers with milk allergies.

    Product
    Factor 75 - Fiery Beef & Black Bean Chili 12.7oz plastic tray sold as single serve meal to end consumer
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-0850-2022·2022-03-16

    Strawberry Coffee Cake Recalled for Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections is recalling its Strawberry Flavor Coffee Cake due to undeclared allergens: egg, milk, and wheat. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chicago Sweet Connections: Coffee Cake - Strawberry Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0843-2022·2022-03-16

    Chicago Sweet Connections Coffee Cake Recalled for Undeclared Egg, Milk, and Wheat Allergens

    Chicago Sweet Connections coffee cake may contain undeclared egg, milk, and wheat allergens. The product was distributed to retail locations in Illinois and Wisconsin.

    Product
    Chicago Sweet Connections: Coffee Cake - Blueberry Flavor packaged in an aluminum rectangular tray with plastic dome lid Single pack - 6 servings
    Category
    Food
    Distribution
    2 states
  • HighCPSC·22104·2022-03-16

    Prestone Shop Pro RV & Marine Antifreeze Recall for Methanol Poisoning Risk

    Prestone has recalled Shop Pro RV & Marine Antifreeze sold at AutoZone after discovering some bottles were improperly filled with methanol-containing product and lack required hazard warnings. Methanol can cause poisoning through inhalation or ingestion and may be fatal or cause blindness.

    Product
    Shop Pro RV & Marine Antifreeze
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2022·2022-03-16

    El Chavito Saladitos Enchilados Salted Plums Recalled for Potential Lead Contamination

    El Chavito Saladitos Enchilados Salted Plums (1.7 oz.) are being recalled nationwide due to potential lead contamination. Consumers should not consume this product.

    Product
    El Chavito¿ Saladitos Enchilados Salted Plums with Chili, net wt. 1.7 oz., Individual UPC 859470006070, Master Case UPC 859470006612.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0830-2022·2022-03-16

    American Gourmet Saladitos Recalled for High Lead Levels

    American Gourmet Saladitos dried salted plums are recalled due to high lead levels detected by California health officials. The 1.5 oz. packages distributed in California should not be consumed.

    Product
    American Gourmet Saladitos (Dried Salted Plums) 1.5 oz. package UPC: 1578600104
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V162000·2022-03-16

    2021 Volkswagen ID.4 Battery Cell Soldering Defect Recall

    Volkswagen is recalling certain 2021 ID.4 vehicles due to improper soldering of the high-voltage battery connection. The defect may cause an unreliable connection that could lead to vehicle stalling and increase crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2022·2022-03-16

    B. Braun dispensing pins recalled for air filter leakage risk

    B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.

    Product
    Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2022·2022-03-16

    CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation

    Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.

    Product
    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2022·2022-03-16

    Alprazolam 1 mg recalled for potential cross-contamination at manufacturer

    Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.

    Product
    Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0651-2022·2022-03-16

    Alprazolam 2 mg tablets recalled due to potential cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.

    Product
    Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0731-2022·2022-03-16

    Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates

    Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-0649-2022·2022-03-16

    Paliperidone Extended-Release Tablets Recalled for Failed Dissolution

    The Harvard Drug Group is recalling 174 cartons of Paliperidone Extended-Release Tablets, 9 mg, nationwide due to failed dissolution specifications. The affected lots are N00522 (Exp. 09/2022) and N00618 (Exp. 11/2022).

    Product
    PALIPERIDONE — PALIPERIDONE (PALIPERIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2022·2022-03-16

    HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors

    Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.

    Product
    HeartWare Ventricular Assist Device (HVAD) System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0744-2022·2022-03-16

    PuraSinus Nasal Hemostat Recalled Due to Unvalidated Shipping Boxes

    3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.

    Product
    PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2022·2022-03-16

    HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads

    Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.

    Product
    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·22V157000·2022-03-15

    2022 Winnebago travel trailers recalled for improperly welded couplers

    Winnebago is recalling certain 2022 Micro Minnie, Minnie, and Voyage travel trailers because the coupler was improperly welded, which may cause the trailer to separate from the tow vehicle and increase crash risk.

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

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