The Recall Desk

Archive

August 2022 recalls

577 recalls were announced in August 2022.

What the numbers show

Critical
6
Severe
89
High
324
Moderate
155
Low
3

Of the 577 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

1–100 of 577

  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • SevereUSDA FSIS·029-2022·2022-08-31

    Valrhona Recalls Ineligible Italian Egg Products

    Valrhona Inc. is recalling approximately 66 pounds of dried albumin egg products produced in Italy, a country ineligible to export egg products to the U.S.

    Product
    Valrhona Inc. Recalls Ineligible Egg Products Produced in Italy
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1561-2022·2022-08-31

    Diaphragm pacing system external pulse generator recalled for circuit board defect

    Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.

    Product
    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Food)·F-1577-2022·2022-08-31

    Tovala gochujang pork bowl meals recalled for undeclared peanut allergen

    Tovala is recalling approximately 3,340 Gochujang-Glazed Pork Chop Bowl meals distributed nationwide because they contain undeclared peanuts, which pose an allergy risk to consumers with peanut allergies.

    Product
    Tovala Gochujang-Glazed Pork Chop Bowl meal No.9-A
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1576-2022·2022-08-31

    Tovala Salmon Meal Recalled Due to Undeclared Peanut Allergen

    Tovala is recalling its Gochujang-Glazed Salmon Bowl meal (No. 18-A) because it contains an undeclared peanut allergen. The affected products were distributed nationwide to consumers.

    Product
    Tovala Gochujang-Glazed Salmon Bowl meal No.18-A
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V658000·2022-08-31

    Shyft Group Recalls 2018-2019 Utilimaster Work Trucks for Frame Weld Defects

    Shyft Group is recalling 2018-2019 Utilimaster Work Trucks because missing or cracked welds on the body mount frame may cause the cargo body to shift, increasing crash risk.

    Product
    UTILIMASTER — UTILIMASTER TRUCK BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2022·2022-08-31

    Medical Lubricating Jelly Recalled Due to Temperature Excursions During Storage

    Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.

    Product
    FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2022·2022-08-31

    Medical disinfectant recalled due to temperature exposure during storage

    McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.

    Product
    a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2022·2022-08-31

    FDA Recalls Exacta-Mix 2400 Compounding System for Potential Valve Leaks

    Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.

    Product
    The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2022·2022-08-31

    Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss

    ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.

    Product
    HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2022·2022-08-31

    McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.

    Product
    a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2022·2022-08-31

    LeadCare II Blood Lead Test Kit Recalled Due to Temperature Storage Issues

    81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.

    Product
    MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2022·2022-08-31

    Medical device recall for temperature exposure during storage

    McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.

    Product
    a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1450-2022·2022-08-31

    Allergy Medications Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling multiple allergy and sinus medications because they were held outside appropriate storage temperature conditions, which may affect their safety and efficacy.

    Product
    QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1391-2022·2022-08-31

    FDA Recalls BC and Goody's Powders Due to Improper Storage Conditions

    Family Dollar Stores is recalling BC Powder and Goody's Powder products due to improper storage temperature conditions. The affected products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2022·2022-08-31

    McKesson blood coagulation test kits recalled for temperature storage damage

    McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.

    Product
    a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1430-2022·2022-08-31

    Multiple eye drop products recalled due to improper storage conditions

    Family Dollar Stores is recalling multiple eye drop products that were held outside appropriate storage temperature conditions. These products were distributed nationwide between April 30 and June 10, 2022.

    Product
    MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE ULTRA HIGH PRFRM LUB DRPS 0.14 FLOZ SKU 901961 LUMIFY REDNESS REL EYE DROPS 2.5 FL OZ SKU 998300 FC EYE DROPS ADVANCED 0.5 OZ SKU 902280 distributed to specific Family Dollar Stores 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1420-2022·2022-08-31

    PREVACID Lansoprazole 15mg Capsules Recalled Due to Storage Conditions

    Family Dollar Stores is recalling PREVACID 24HR Lansoprazole 15mg capsules distributed nationwide from April 30 to June 10, 2022, because the product was stored at improper temperatures in violation of manufacturing standards. Consumers should not use this product and should contact Family Dollar Stores for a refund.

    Product
    PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1418-2022·2022-08-31

    Good Sense Esomeprazole Acid Reducer Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Good Sense Esomeprazole Acid Reducer 20mg bottles due to storage temperature deviations. Affected bottles were distributed between April 30 and June 10, 2022.

    Product
    GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2022·2022-08-31

    ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure

    Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.

    Product
    a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2022·2022-08-31

    Servo-air Ventilator Systems Lack Required Stability Warning Markings

    Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.

    Product
    Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2022·2022-08-31

    Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk

    Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.

    Product
    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2022·2022-08-31

    Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss

    Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.

    Product
    BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Serie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2022·2022-08-31

    Enjoy Life Breakfast Ovals Recalled for Potential Hard Plastic Pieces

    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals (Berry Medley) are being recalled due to potential hard plastic contamination. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals Berry Medley, 8.8 oz (250g) UPC 819597012583 and 819597012712
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1580-2022·2022-08-31

    Bob's Red Mill Amaranth Grain recalled for potential Salmonella contamination

    Bob's Red Mill Organic Amaranth Grain is being recalled due to potential Salmonella contamination. Affected products were distributed across multiple U.S. states and the Philippines.

    Product
    Organic Amaranth Grain Gluten Free, Bob's Red Mill brand, packaged in Standup Pouch (24oz). Each case consists of 4/24 oz. pouches. RETAIL Pouch UPC 0 39978 02910 2. RETAIL Case UPC 10039978029109. Organic Amaranth Grain Gluten Free, Organic Amaranth Grain, packaged in Kraft
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1607-2022·2022-08-31

    Chest Drain System Atrium 2100 mL recalled due to temperature exposure

    The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.

    Product
    GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1457-2022·2022-08-31

    Mucinex FastMax Caplets Cold Flu Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling Mucinex FastMax Caplets Cold Flu 4CT (SKU 903372) distributed nationwide from April to June 2022 due to improper storage temperature conditions.

    Product
    MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1573-2022·2022-08-31

    Enjoy Life Brownie Bites recalled for potential hard plastic pieces

    Enjoy Life Natural Brands is recalling Brownie Bites - Salted Caramel (4.76 oz) due to potential hard plastic pieces. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Brownie Bites Salted Caamel, 4.76 oz UPC 819597013313
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1568-2022·2022-08-31

    Enjoy Life Chewy Bars Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Chewy Bars - Caramel Blondie due to potential hard plastic pieces. About 89,736 cases were distributed in the US and Canada.

    Product
    Enjoy Life Chewy Bars Caramel Blondie (Chocolate Chip and Caramel), 5.75 oz (165g) UPC 819597011258 and 819597011333
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2022·2022-08-31

    3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure

    3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.

    Product
    3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1572-2022·2022-08-31

    Enjoy Life Brownie Bites Recalled for Potential Hard Plastic Pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Brownie Bites Rich Chocolate (UPC 819597013290) due to potential hard plastic pieces in the product. No illnesses have been reported.

    Product
    Enjoy Life Brownie Bites Rich Chocolate, 4.76 oz UPC 819597013290
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1579-2022·2022-08-31

    Capriole Goat Cheese recalled for undeclared food dyes

    Capriole Fresh Goat Cheese products containing undeclared Blue #1 and Yellow #5 dyes are being recalled. Affected products were distributed in Kentucky, Illinois, and Indiana.

    Product
    Capriole Goat Cheese, Fresh Goat Cheese, Wasabi 5 pound and 8oz logs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1570-2022·2022-08-31

    Enjoy Life Oat Breakfast Ovals Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals due to potential hard plastic pieces in the product. Consumers should not consume affected items.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals Chocolate Chip Banana, 8.8 oz (250g) UPC 819597012576 and 819597012705
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1574-2022·2022-08-31

    Enjoy Life Soft Baked Cookies Recalled for Potential Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies (36 oz Amazon Variety Pack) nationwide due to potential hard plastic contamination. Approximately 89,736 cases are affected.

    Product
    Enjoy Life Soft Baked Cookies - 36 oz. Amazon Variety Pack - (2SND,1CC,1OAT,1SBCC,1MSTR; 6oz. each) UPC 819597014518
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V657000·2022-08-31

    2022 Volkswagen Atlas trailer hitch bolts may loosen and separate

    Volkswagen is recalling certain 2022 Atlas and Atlas Cross Sport vehicles because trailer hitch bolts may be insufficiently tightened. Loose bolts could fall out and cause the trailer hitch to separate, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1564-2022·2022-08-31

    Enjoy Life Soft Baked Cookies Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Soft Baked Cookies Double Chocolate Brownie due to potential hard plastic contamination. Consumers should not eat the affected product.

    Product
    Enjoy Life Soft Baked Cookies Double Chocolate Brownie, 6 oz (170g) UPC 853522000214
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1400-2022·2022-08-31

    ZzzQuil Night Pain Berry Recalled Due to Improper Storage

    ZzzQuil Night Pain Berry 12 FL OZ distributed to Family Dollar Stores from April 30 through June 10, 2022, was held outside appropriate storage temperature conditions, which may compromise medication stability and integrity.

    Product
    ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1464-2022·2022-08-31

    Hand sanitizer recalled for use of expired active ingredient

    Corsair Personal Care 99X Instant Foam Hand Sanitizer is being recalled due to a manufacturing violation: it was made using expired benzalkonium chloride. Consumers should stop using the affected product.

    Product
    Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1431-2022·2022-08-31

    Topical Skincare Products Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling three topical skincare products distributed nationwide due to storage condition violations in manufacturing.

    Product
    ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5 OZ SKU 2097153 CC BLACKHEAD SCRUB 5 OZ SKU 2032021 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1402-2022·2022-08-31

    Petroleum Jelly Products Recalled for Improper Storage Conditions

    Family Dollar Stores is recalling three petroleum jelly products (Swan, Baby Love, and Vaseline brands) distributed between April and June 2022 due to storage temperature deviations.

    Product
    SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU 910726 VASELINE PETROLEUM JELLY ORIGINAL 7.5 OZ 2099273 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1367-2022·2022-08-31

    Multiple Toothpaste and Dental Care Products Recalled for Improper Storage

    Family Dollar Stores is recalling multiple toothpaste and dental care products that were stored outside appropriate temperature conditions, distributed April 30–June 10, 2022.

    Product
    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1381-2022·2022-08-31

    Family Dollar Oral Pain Relief Products Recalled for Improper Storage

    Family Dollar recalled multiple oral pain relief products due to storage temperature deviations. The products were distributed to select Family Dollar stores from April 30, 2022 through June 10, 2022.

    Product
    ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU 999543 ORAJEL ORAL PAIN 0.125 FL OZ SKU 912968 ORAJEL MOUTH SORE GEL 0.125 OZ SKU 999075 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2022·2022-08-31

    B. Braun Gravity Mixing Container Recalled for Temperature Exposure

    B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.

    Product
    B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2022·2022-08-31

    LASIK Irrigation Cannula Recalled for Potential Temperature Exposure Damage

    Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1582-2022·2022-08-31

    Homemade Bofrot/Puff Puff Mix Recalled for Undeclared Wheat Allergen

    Pegroks Kitchen is recalling Homemade Bofrot/Puff Puff mix (24 oz packages) due to undeclared wheat allergen. Consumers with wheat allergies should not consume this product.

    Product
    Homemade Bofrot/Puff Puff mix, Pegroks Kitchen 24 ounce packages - 12 packages per case packaged in purple mylar bags
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1591-2022·2022-08-31

    Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage

    Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.

    Product
    Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1408-2022·2022-08-31

    Witch hazel product recalled for improper storage temperature conditions

    Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.

    Product
    TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1575-2022·2022-08-31

    Abbott Jevity Complete Enteral Nutrition Product Recalled for Potential Bottle Leaks

    Abbott Laboratories is recalling Abbott Jevity Complete enteral nutrition products due to potential leaking or pinholes in the bottles. The recall affects 179 cases distributed to healthcare facilities in seven states.

    Product
    Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1569-2022·2022-08-31

    Enjoy Life Breakfast Ovals Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Soft Baked Fruit & Oat Breakfast Ovals (Apple Cinnamon) due to potential hard plastic pieces in the product. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals - Apple Cinnamon, 8.8 oz. UPC 819597012569
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1426-2022·2022-08-31

    GC Milk of Magnesia Recalled for Storage Temperature Deviation

    GC Milk of Magnesia products (Cherry and Mint, 12 fl oz) distributed to Family Dollar Stores have been recalled due to improper storage temperature. The products may not meet quality and performance standards.

    Product
    GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 FL OZ SKU 915623 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1562-2022·2022-08-31

    Enjoy Life and Trader Joe's Soft Baked Cookies Recalled for Hard Plastic Pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies (Snickerdoodle) and Trader Joe's Soft-Baked Snickerdoodles due to potential hard plastic pieces in the products. Consumers should not eat affected packages.

    Product
    Enjoy Life Soft Baked Cookies Snickerdoodle, 6 oz .(170g) UPC 853522000184 Trader Joe's Soft-Baked Snickerdoodles, 6 oz. UPC 0094 0757
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V660000·2022-08-31

    2022 Nissan Rogue Fuel Tank May Leak Following Modifications

    Certain 2022 Nissan Rogue vehicles have fuel tanks that may have been punctured during vehicle modifications, creating potential fuel leak and fire risk. Nissan will inspect and replace affected fuel tanks free of charge.

    Product
    NISSAN — NISSAN redundant ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1390-2022·2022-08-31

    Rubbing Alcohol Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores recalled Ready In Case 50% Wintergreen Rubbing Alcohol (16 fl oz) distributed April 30–June 10, 2022 due to improper storage temperature conditions.

    Product
    READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1387-2022·2022-08-31

    Topical ointment recall due to improper storage temperature conditions

    Family Dollar Stores is recalling AD PREV OINT ORIG 4 OZ due to improper storage conditions that may affect product quality. Products distributed nationwide from April 30 through June 10, 2022 are affected.

    Product
    AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1372-2022·2022-08-31

    Tylenol and Acetaminophen Products Recalled Due to Improper Storage

    Family Dollar Stores is recalling multiple Tylenol and acetaminophen products due to CGMP deviations involving improper storage temperature conditions. Products were distributed nationwide through specific Family Dollar locations from April 30, 2022 through June 10, 2022.

    Product
    Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 91698
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1444-2022·2022-08-31

    AFRIN No Drip Severe Congestion Recalled for Improper Storage Temperature

    Family Dollar Stores is recalling AFRIN No Drip Severe Congestion 0.5 FL oz due to improper storage temperature conditions (CGMP deviation). The product was distributed to specific Family Dollar locations from April 30 through June 10, 2022.

    Product
    AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2022·2022-08-31

    Enjoy Life Chewy Bars recalled for hard plastic pieces

    Enjoy Life Natural Brands is recalling Chewy Bars Sunseed Crunch due to potential hard plastic fragments in the product. Affected products were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Chewy Bars Sunseed Crunch, 5.75 oz UPC 853522000627
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2022·2022-08-31

    DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

    DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

    Product
    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1362-2022·2022-08-31

    Divalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling 4,309 bottles of Divalproex Sodium Extended-Release Tablets (250 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2022·2022-08-31

    Boston Scientific Guide Catheter Distributed With Wrong Tip Curve

    Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.

    Product
    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1606-2022·2022-08-31

    Alere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage

    Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for potential hard plastic contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies Sunseed Butter Chocolate Chip due to potential hard plastic pieces in the product. The recall affects approximately 89,736 cases distributed nationwide in the US and Canada.

    Product
    Enjoy Life Soft Baked Cookies Sunseed Butter Chocolate Chip, 6 oz. UPC 819597013801
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1454-2022·2022-08-31

    Multiple Cold and Flu Medications Recalled Due to Improper Storage Conditions

    Family Dollar Stores is recalling multiple cold and flu medications distributed April 30–June 10, 2022, because products were held outside appropriate storage temperature conditions.

    Product
    DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CI
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1443-2022·2022-08-31

    Good Sense Lice Shampoo Recalled for Improper Storage Conditions

    Family Dollar Stores recalls Good Sense Lice Shampoo 6 FL OZ distributed April-June 2022 nationwide due to CGMP deviations from improper storage temperature conditions. Products may have compromised safety or efficacy.

    Product
    GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1432-2022·2022-08-31

    Facial Moisturizer Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores is recalling AMBI Nursing Daily Facial Moisturizer 1.7 oz distributed nationwide from April 30 through June 10, 2022, because the product was held outside appropriate storage temperature conditions.

    Product
    AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1388-2022·2022-08-31

    Arthritis Pain Reliefs Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores is recalling BC Arthritis Pain Fast Pain Relief and Good Sense Arthritis Caplet due to improper storage conditions. Products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU 914771 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2022·2022-08-31

    Central Venous Catheter Kits Recalled for Potential Temperature Damage

    McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.

    Product
    TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1442-2022·2022-08-31

    Mylicon Infant Gas Drops Recalled Due to Temperature Storage Deviation

    Family Dollar Stores is recalling Mylicon Infant Gas Drops 0.5 oz distributed nationwide from April 30 through June 10, 2022 due to improper storage temperature conditions.

    Product
    MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2022·2022-08-31

    Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage

    Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1364-2022·2022-08-31

    AMBI Skin Cream Recalled Due to Improper Storage Conditions

    AMBI Skin Cream for normal and oily skin was recalled due to storage temperature deviations. Products were distributed to Family Dollar Stores between April and June 2022.

    Product
    AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2022·2022-08-31

    Drug screening tablets affected by temperature exposure during storage

    McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.

    Product
    Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1384-2022·2022-08-31

    Family Dollar Hydrocortisone and Cortizone Creams Recalled for Storage Deviation

    Family Dollar Stores is recalling hydrocortisone cream (1 oz, SKU 910321) and Cortizone 10 Creme (0.5 oz, SKU 910167) distributed April 30 through June 10, 2022, due to improper storage temperature conditions.

    Product
    FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1365-2022·2022-08-31

    Sunscreen Products Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling multiple sunscreen products that were stored outside appropriate temperature conditions. The storage deviation may have reduced the products' sun protection effectiveness.

    Product
    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2022·2022-08-31

    MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss

    McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.

    Product
    MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1462-2022·2022-08-31

    Vicks DayQuil NyQuil Combination Pack Recalled for Storage Temperature

    Family Dollar Stores is recalling Vicks DayQuil/NyQuil Liquid combination packs (SKU 903367) distributed from April 30 to June 10, 2022, due to improper storage temperatures that may affect medication effectiveness.

    Product
    VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2022·2022-08-31

    Centurion Catheter Kits Recalled Due to Temperature Exposure

    Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.

    Product
    CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2022·2022-08-31

    Medical Device Recall: Wetfield Eraser Bipolar Hemostatic due to temperature exposure

    McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.

    Product
    Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1374-2022·2022-08-31

    Antifungal Cream Recalled for Improper Storage Temperature Conditions

    Family Dollar's FS Clotrimazole Anti Fungal Cream is being recalled due to improper storage temperature conditions. The product was distributed nationwide between April 30 and June 10, 2022.

    Product
    FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1429-2022·2022-08-31

    MIRALAX 8.3 OZ Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling MIRALAX 8.3 OZ (SKU 902219) distributed nationwide from April 30 to June 10, 2022. The product was held outside appropriate storage temperatures, violating manufacturing standards.

    Product
    MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1455-2022·2022-08-31

    QP Sudfedrine PE Max Strength tablets recalled for improper storage

    Family Dollar Stores is recalling QP Sudfedrine PE Max Strength tablets nationwide due to storage temperature deviations that may have compromised product quality.

    Product
    QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2022·2022-08-31

    Surgical ophthalmic wicks recalled for potential effectiveness loss

    McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2022·2022-08-31

    GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

    GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

    Product
    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Drugs)·D-1398-2022·2022-08-31

    AZO YEAST PLUS 20 CT Recalled Due to Improper Storage Conditions

    AZO YEAST PLUS 20 CT has been recalled by Family Dollar Stores due to improper storage temperature conditions that violate CGMP requirements. The product was distributed nationwide from April through June 2022.

    Product
    AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for hard plastic pieces

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies Monster (6 oz) due to potential hard plastic pieces. The recall affects 89,736 cases distributed nationwide in the US and Canada with best-by dates between 2/6/2023 and 3/3/2023.

    Product
    Enjoy Life Soft Baked Cookies Monster, 6 oz. UPC 819597013818
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2022·2022-08-31

    Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage

    Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.

    Product
    Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2022·2022-08-31

    Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness

    Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.

    Product
    NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2022·2022-08-31

    Medical Sponges Recalled for Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.

    Product
    METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Risk

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier. The product was distributed nationwide and internationally.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1401-2022·2022-08-31

    Jet Alert Tablets Recalled for Improper Storage Temperature Conditions

    Jet Alert stimulant tablets distributed nationwide from April to June 2022 are being recalled due to improper storage temperature conditions that may affect product safety and efficacy.

    Product
    JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2022·2022-08-31

    McKesson GYNECATH H/S Catheter Recalled Due to Temperature Excursions Prior to Delivery

    McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.

    Product
    Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2022·2022-08-31

    Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure

    Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.

    Product
    Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1563-2022·2022-08-31

    Enjoy Life Soft Baked Cookies recalled for potential hard plastic pieces

    Enjoy Life Natural Brands is recalling Soft Baked Chocolate Chip Cookies nationwide due to potential hard plastic contamination. Affected products have Best By dates from February to March 2023.

    Product
    Enjoy Life Soft Baked Cookies Chocolate Chip, 6 oz. (170g) UPC 853522000191
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1383-2022·2022-08-31

    FDA Recalls NPX Antibiotic Ointments for Improper Storage Temperature

    Family Dollar Stores is recalling three NPX antibiotic ointment products due to improper storage temperature conditions that may affect product quality. Consumers should return or discard the products.

    Product
    NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ SKU 999855 NPX TRPL ANTIBIOTIC PLS PAIN OINMNT 1 OZ SKU 901498 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2022·2022-08-31

    Mckesson Ultracell Eye Pledgets Recalled Over Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.

    Product
    Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
    Category
    Medical Device
    Distribution
    Distributed nationwide

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