The Recall Desk

Archive

June 2019 recalls

686 recalls were announced in June 2019.

What the numbers show

Critical
12
Severe
191
High
347
Moderate
123
Low
13

Of the 686 recalls this month scored against our rubric, 2% are Critical, 28% are Severe.

601–686 of 686

  • HighFDA (Devices)·Z-1656-2019·2019-06-05

    Maquet Getinge Infant ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2019·2019-06-05

    Maquet Getinge-T 8030 High Flow Pigtail Tubing Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1650-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2019·2019-06-05

    Maquet Getinge-BEQ-TOP Adult Specialty Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific adult specialty tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2019·2019-06-05

    Maquet Getinge Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

    Teleflex Medical is recalling RUSCH LASERTUBE devices because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent sterilization gas from reaching all fluid paths.

    Product
    Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 35503 SGD Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2019·2019-06-05

    Maquet Getinge Tubing Packs Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing packs for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1657-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2019·2019-06-05

    Maquet Getinge Children's ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Children's Large ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2019·2019-06-05

    Maquet Getinge Rotaflow Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Rotaflow Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2019·2019-06-05

    Maquet Getinge Adult ECC Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2019·2019-06-05

    Maquet Getinge Sash and Accessory Pack Recall for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Sash & Accessory Packs because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2019·2019-06-05

    Maquet Getinge-T AV Manifold Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge-BO-TOP 30300 Material:701052623
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22701 Material: 701050790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 5208 ECC Set Cardiac Recall for Sterility Assurance

    Maquet Cardiovascular is recalling specific batches of cardiac extracorporeal circulation sets because a design flaw may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2019·2019-06-05

    Maquet Getinge Rotaflow Support Pack Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Rotaflow Support Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation due to a sterilization defect that may compromise sterility.

    Product
    Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2019·2019-06-05

    Abbott Alinity i Processing Module Recalled for Potential Burn and Shock Hazards

    Abbott is recalling Alinity i Processing Modules due to potential loose cable connections that could cause reagent cooler failure, leading to burn or shock injuries.

    Product
    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1667-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1529-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of stopcock ports.

    Product
    Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 26402 ECC Pack Recall Due to Sterility Concerns

    Maquet Cardiovascular is recalling specific batches of ECC Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1408-2019·2019-06-05

    Oakhouse Bakery Recalls Coconut Cashew Granola for Foreign Material

    Oakhouse Bakery is recalling purely elizabeth Coconut Cashew Grain-Free Granola because it may contain pieces of foreign material.

    Product
    purely elizabeth Coconut Cashew Grain-Free Granola, packaged in Net Wt. 8 oz. (227g) Re-sealable Pouch, UPC 55140-00270, and Net Wt. 16 oz. (1LB) Re-sealable Pouch, UPC 55140-00294. Made with organic hemp, chia, and coconut flakes. Distributed By: Purely Elizabeth, LLC, Bould
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1688-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1313-2019·2019-06-05

    Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.

    Product
    INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1412-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Peanut Butter Grain-Free Bars

    Oakhouse Bakery is recalling Purely Elizabeth Peanut Butter Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Peanut Butter Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00207. Display Carton UPC 10589-03004. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1310-2019·2019-06-05

    Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.

    Product
    ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1425-2019·2019-06-05

    Dole Colourful Coleslaw Recalled Due to Soft Plastic Contamination

    Dole Fresh Vegetables is recalling Dole Colourful Coleslaw because complaints were received regarding irregular pieces of soft plastic in the product.

    Product
    Dole Colourful Coleslaw ( Salade Chou Coloree) - Canada Shredded green and red cabbage and carrots. Net Wt. 3 lbs. 1.36 kg
    Category
    Food
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-1319-2019·2019-06-05

    Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations

    Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.

    Product
    Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 N
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1312-2019·2019-06-05

    Inopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations

    Inopak Ltd is recalling DermaGel and SaniTyze hand sanitizers because they were not produced under current good manufacturing practices.

    Product
    Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1414-2019·2019-06-05

    Oakhouse Bakery Recalls Pumpkin Spice Granola for Foreign Material

    Oakhouse Bakery is recalling 2,545 cases of purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola because the product may contain pieces of foreign material.

    Product
    purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 10589-03015. made with organic chia, dodonut flakes and ashwagandha. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1428-2019·2019-06-05

    Hilmar Recalls Colby Jack Cheese Blocks Due to Foreign Material

    Hilmar Cheese Company is recalling specific batches of Colby Jack Cheese in 40 and 640-pound blocks because they may contain foreign material. The product was distributed in Missouri, Minnesota, and Wisconsin.

    Product
    Colby Jack Cheese in 40 pound and 640 pound blocks
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1416-2019·2019-06-05

    Oakhouse Bakery Recalls GreenWise Granola for Foreign Material

    Oakhouse Bakery is recalling GreenWise Cinnamon Peanut Butter Grain-Free Granola because it may contain pieces of foreign material.

    Product
    GreenWise Cinnamon Peanut Butter Grain-Free Granola, Net Wt. 8 oz. (226g) Re-sealable Pouch. UPC 41415-18005. Made with organic sunflower seeds, organic pumpkin seeds, and organic coconut flakes. Distributed by Publix Super Markets, Inc., Lakeland, FL 33802.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1317-2019·2019-06-05

    Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.

    Product
    Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1409-2019·2019-06-05

    Oakhouse Bakery Recalls Granola for Potential Foreign Material Contamination

    Oakhouse Bakery is recalling purely elizabeth Banana Nut Butter Grain-Free Granola because it may contain pieces of foreign material.

    Product
    purely elizabeth Banana Nut Butter Grain-Free Granola, Net Wt. 8 oz. (227g) Re-sealable Pouch. UPC 55140-00272. Made with organic hemp, chia, and coconut flakes. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1413-2019·2019-06-05

    Oakhouse Bakery Recalls Coconut Cashew Grain-Free Bars Due to Foreign Material

    Oakhouse Bakery is recalling purely elizabeth Coconut Cashew Grain-Free Bars because they may contain pieces of foreign material.

    Product
    purely elizabeth Coconut Cashew Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00213. Display Carton UPC 10589-03007. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1681-2019·2019-06-05

    King LTS-D Kit Size 1 Recalled for Incorrect Packaging and Labeling

    King Systems Corp. dba Ambu, Inc. is recalling 270 King LTS-D Kit Size 1 units because they were incorrectly packaged and labeled as size 1 products.

    Product
    King LTS-D Kit Size 1, Model Number KLTSD431
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-1411-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Chocolate Sea Salt Grain-Free Bars

    Oakhouse Bakery is recalling Purely Elizabeth Chocolate Sea Salt Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Chocolate Sea Salt Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00208. Display Carton UPC 10589-03006. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1424-2019·2019-06-05

    Dole Classic Coleslaw Recalled Due to Soft Plastic Contamination

    Dole Fresh Vegetables is recalling 6,255 cases of Classic Coleslaw (US) because of complaints regarding irregular pieces of soft plastic found in the product.

    Product
    Dole Classic Coleslaw (US) Shredded cabbage and carrots. 14 oz. US
    Category
    Food
    Distribution
    31 states
  • ModerateFDA (Food)·F-1410-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Banana Nut Butter Bars

    Oakhouse Bakery is recalling Purely Elizabeth Banana Nut Butter Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Banana Nut Butter Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00209. Display Carton UPC 10589-03005. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1417-2019·2019-06-05

    Oakhouse Bakery Recalls Specially Selected Paleo Granola for Foreign Material

    Oakhouse Bakery is recalling Specially Selected Paleo Granola, Grain Free Maple Almond sold at Aldi in Arkansas and Colorado because the product may contain pieces of foreign material.

    Product
    Specially Selected Paleo Granola, Grain Free. Maple Almond, Net Wt. 8 oz. (227g) Reclosable Bag. UPC 4099100040067. A blend of nuts and Seeds with Maple Syrup, Raisins, and Cinnamon. Dist & Sold Exclusively by: Aldi, Batavia, IL 60510
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1316-2019·2019-06-05

    Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations

    Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.

    Product
    Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1315-2019·2019-06-05

    Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1311-2019·2019-06-05

    Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were not produced under current good manufacturing practices.

    Product
    AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1690-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling three units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to cold storage equipment failure.

    Product
    Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1689-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech, Inc. is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1415-2019·2019-06-05

    Oakhouse Bakery Recalls GreenWise Cranberry Cashew Granola Due to Foreign Material

    Oakhouse Bakery is recalling GreenWise Cranberry Cashew Granola because it may contain pieces of foreign material. The product was distributed in Arkansas and Colorado.

    Product
    GreenWise Cranberry Cashew Granola, Net Wt. 12 oz. (340g) Re-sealable Pouch. UPC 41415-18305. Made with organic oats. Distributed by Publix Super Markets, Inc., Lakeland, FL 33802.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1314-2019·2019-06-05

    Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

    Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.

    Product
    INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2019·2019-06-05

    K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.

    Product
    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and mai
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1686-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Partial Foil Separation

    Teleflex Medical is recalling 2,325 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2019·2019-06-05

    K2M Fenestrated Taps Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Taps because the products are mislabeled. The devices were distributed to six US states.

    Product
    Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration tech
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1318-2019·2019-06-05

    Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V412000·2019-06-04

    Honda Recalls 2018-2019 Motorcycles Due to Transmission Shaft Defect

    Honda is recalling specific 2018 and 2019 motorcycles because a transmission part may detach, causing gear misalignment that increases crash risk.

    Product
    HONDA — HONDA CB300R, CMX300, CRF250L, CBR300R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19750·2019-06-04

    Polaris Recalls 2015-2019 Ranger EV Vehicles Due to Crash Hazard

    Polaris is recalling about 3,900 Ranger EV recreational off-highway vehicles due to a wiring defect that can cause unexpected acceleration and crashes.

    Product
    Model Year 2015 - 2019 Polaris RGR EV recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V411000·2019-06-04

    Ferrari Recalls Multiple Models Due to Air Bag Control Module Malfunction

    Ferrari is recalling 893 vehicles because the air bag control module may malfunction, potentially causing air bags or seat belt pretensioners to fail to deploy or deploy improperly.

    Product
    FERRARI — FERRARI F12 BERLINETTA, CALIFORNIA T, 488 GTB, 488 SPIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19131·2019-06-04

    Generation Brands Recalls Small Stratton Glass Pendant Light Fixtures

    Generation Brands is recalling Small Stratton glass pendant light fixtures because they can detach from the cord and fall, posing an injury risk.

    Product
    Small Stratton glass pendant light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19749·2019-06-04

    Polaris Recalls 2019 RZR XP 4 Turbo S Vehicles Due to Brake Failure

    Polaris is recalling about 1,200 Model Year 2019 RZR XP 4 Turbo S recreational off-highway vehicles because the brakes can fail, posing crash and injury hazards.

    Product
    Model Year 2019 Polaris RZR XP 4 Turbo S recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide

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