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Recalls affecting California

Data last updated: September 9, 2026 at 1:18 PM UTC

17,393 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Under certain conditions, a marble pattern infrequently appears on the monitor.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85299
Lot/product code:
RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.
Recalling firm:
Eizo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Under certain conditions, a marble pattern infrequently appears on the monitor.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85299
Lot/product code:
RadiForce GX560 - 1.0003 or earlier
Recalling firm:
Eizo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 1, 2019

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
83491
Lot/product code:
Part Numbers:   1. 7590310-24;   2. 7590310-40;   3. 7590311-24;   4. 7590311-40;   5. 7590312-24;   6. 7590312-40;   7. 7590313-24;   8. 7590313-40;   9. 7590314-24;   10. 7590314-40;   11. 7590315-24;   12. 7590315-40;   13. 7590316-24;   14. 7590316-40;   15. 7590317-24;   16. 7590317-40;   17. 7590318-24-5;   18. 7590318-24-7;   19. 7590318-40-5;   20. 7590318-40-7;   21. 7590319-24-5;   22. 7590319-40-5;   23. 7590440;   24. 7590441;   25. 7590442;   26. 7590443;   27. 7590444;   28. 7590445;   29. 7590446;   30. 7590447;   31. 7590450-5;   32. 7590450-8
Recalling firm:
GN Otometrics
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Samples in the identified lot were found to have incomplete or open packaging seals.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83551
Lot/product code:
Lot Number 19CAB954
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare FD&C Yellow #5 and FD&C Yellow #6.

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A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2105-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G)

Failure to declare Soy, FD&C Yellow #5 and #6 and lack of Keep Refrigerated labeling.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2104-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare Sodium Metabisulfite.

ALL 50 STATES
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-2106-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Proteus XR/a (SlOK : K993090)

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83647
Lot/product code:
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
85324
Lot/product code:
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
84859
Lot/product code:
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Recalling firm:
RESPIRATORY THERAPEUTICS GROUP LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83558
Lot/product code:
Model A219, Serial Number (Use Before Date) - 213636 (7/21/2019), 213637 (7/21/2019), 213638 (7/21/2019), 213639 (7/21/2019), 213640 (7/21/2019), 213641 (7/21/2019), 213642 (7/21/2019), 213643 (7/21/2019), 213644 (7/21/2019), 213645 (7/21/2019), 213646 (7/21/2019), 213647 (7/21/2019), 213648 (7/21/2019), 213649 (7/21/2019), 213650 (7/21/2019), 213651 (7/21/2019), 213652 (7/21/2019), 213653 (7/21/2019), 213654 (7/21/2019), 213655 (7/21/2019), 213656 (7/21/2019), 213657 (7/21/2019), 213658 (7/21/2019), 213659 (7/21/2019), 213660 (7/21/2019), 213661 (7/21/2019), 213662 (7/21/2019), 213663 (7/21/2019), 213665 (7/21/2019), 213666 (7/21/2019), 213667 (7/21/2019), 213668 (7/21/2019), 213669 (7/21/2019), 213670 (7/21/2019), 213671 (7/21/2019), 213672 (7/21/2019), 213673 (7/21/2019), 213674 (7/21/2019), 213675 (7/21/2019), 213676 (7/21/2019), 213677 (7/21/2019), 213678 (7/21/2019), 213679 (7/21/2019), 213680 (7/21/2019), 213681 (7/21/2019), 213682 (7/21/2019), 213683 (7/21/2019), 213684 (7/21/2019), 213685 (7/21/2019), 213686 (7/24/2019), 213687 (7/24/2019), 213688 (7/24/2019), 213689 (7/24/2019), 213690 (7/24/2019), 213691 (7/24/2019), 213692 (7/24/2019), 213693 (7/24/2019), 213694 (7/24/2019), 213695 (7/24/2019), 213696 (7/24/2019), 213697 (7/24/2019), 213698 (7/24/2019), 213699 (7/24/2019), 213700 (7/24/2019), 213701 (7/24/2019), 213702 (7/24/2019), 213703 (7/24/2019), 213704 (7/24/2019),  213705 (7/24/2019), 213706 (7/24/2019), 213707 (7/24/2019), 213708 (7/24/2019), 213709 (7/24/2019), 213710 (7/24/2019), 213712 (7/24/2019), 213713 (7/24/2019), 213714 (7/24/2019), 213715 (7/24/2019), 213716 (7/24/2019), 213717 (7/24/2019), 213718 (7/24/2019), 213719 (7/24/2019), 213720 (7/24/2019), 213721 (7/24/2019), 213722 (7/24/2019), 213723 (7/24/2019), 213724 (7/24/2019), 213726 (7/24/2019), 213727 (7/24/2019), 213728 (7/24/2019), 213730 (7/24/2019), 213731 (7/24/2019), 213732 (7/24/2019), 213733 (7/24/2019), 213734 (7/24/2019), 213735 (7/24/2019), 213736 (7/24/2019), 213737 (7/24/2019), 213738 (7/24/2019), 213739 (7/24/2019), 213740 (7/24/2019), 213741 (7/24/2019), 213742 (7/24/2019), 213743 (7/24/2019), 213744 (7/24/2019), 213745 (7/24/2019), 213746 (7/25/2019), 213747 (7/25/2019), 213748 (7/25/2019), 213749 (7/25/2019), 213750 (7/25/2019), 213751 (7/25/2019), 213752 (7/25/2019), 213753 (7/25/2019), 213754 (7/25/2019), 213755 (7/25/2019), 213756 (7/25/2019), 213757 (7/25/2019), 213758 (7/25/2019), 213759 (7/25/2019), 213760 (7/25/2019), 213761 (7/25/2019), 213762 (7/25/2019), 213763 (7/25/2019), 213764 (7/25/2019), 213765 (7/25/2019), 213766 (7/25/2019), 213767 (7/25/2019), 213768 (7/25/2019), 213769 (7/25/2019), 213770 (7/25/2019), 213771 (7/25/2019), 213772 (7/25/2019), 213773 (7/25/2019), 213774 (7/25/2019), 213775 (7/25/2019), 213776 (7/25/2019), 213777 (7/25/2019), 213778 (7/25/2019), 213779 (7/25/2019), 213780 (7/25/2019), 213782 (7/25/2019), 213783 (7/25/2019), 213784 (7/25/2019), 213785 (7/25/2019), 213786 (7/25/2019), 213787 (7/25/2019), 213788 (7/25/2019), 213789 (7/25/2019), 213790 (7/25/2019), 213791 (7/25/2019), 213792 (7/25/2019), 213793 (7/25/2019), 213794 (7/25/2019), 213795 (7/25/2019), 213796 (7/25/2019), 213797 (7/25/2019), 213798 (7/25/2019), 213799 (7/25/2019), 213800 (7/25/2019), 213801 (7/25/2019), 213802 (7/25/2019), 213803 (7/25/2019), 213804 (7/25/2019), 213805 (7/25/2019), 213806 (7/25/2019), 213807 (7/25/2019), 213808 (7/25/2019), 213809 (7/25/2019), 213810 (7/25/2019), 213811 (7/25/2019), 213812 (7/25/2019), 213813 (7/25/2019), 213814 (7/25/2019), 213815 (7/25/2019), 213816 (7/26/2019), 213817 (7/26/2019), 213818 (7/26/2019), 213819 (7/26/2019), 213820 (7/26/2019), 213821 (7/26/2019), 213822 (7/26/2019), 213823 (7/26/2019), 213824 (7/26/2019), 213826 (7/26/2019), 213827 (7/26/2019), 213828 (7/26/2019), 213830 (7/26/2019), 213831 (7/26/2019), 213832 (7/26/2019), 213833 (7/26/2019), 213834 (7/26/2019), 213835 (7/26/2019), 213836 (7/26/2019), 213837 (7/26/2019), 213838 (7/26/2019), 213839 (7/26/2019), 213840 (7/26/2019), 213841 (7/26/2019), 213843 (7/26/2019), 213844 (7/26/2019), 213845 (7/26/2019), 213846 (7/26/2019), 213847 (7/26/2019), 213848 (7/26/2019), 213849 (7/26/2019), 213850 (7/26/2019), 213851 (7/26/2019), 213852 (7/26/2019), 213853 (7/26/2019), 213854 (7/26/2019), 213855 (7/26/2019), 213856 (7/26/2019), 213857 (7/26/2019), 213858 (7/26/2019), 213860 (7/26/2019), 213861 (7/26/2019), 213862 (7/26/2019), 213863 (7/26/2019), 213864 (7/26/2019), 213865 (7/26/2019), 213866 (7/26/2019), 213867 (7/26/2019), 213868 (7/26/2019), 213869 (7/26/2019), 213870 (7/26/2019), 213871 (7/26/2019), 213872 (7/26/2019), 213874 (7/26/2019), 213875 (7/26/2019), 213876 (7/26/2019), 213877 (7/26/2019), 213878 (7/26/2019), 213879 (7/26/2019), 213880 (7/26/2019), 213881 (7/26/2019), 213882 (7/26/2019), 213883 (7/26/2019), 213884 (7/26/2019), 213885 (7/26/2019), 213886 (7/27/2019), 213887 (7/27/2019), 213888 (7/27/2019), 213889 (7/27/2019), 213890 (7/27/2019), 213892 (7/27/2019), 213893 (7/27/2019), 213894 (7/27/… (truncated, 8125 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83558
Lot/product code:
Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2019

Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

ALAZCACOCTDEFLGAILINMAMDMIMNMONCNHNJOHORPASCTNTXVAWAWIWV
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
84896
Lot/product code:
All Lots
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2019

Karl Storz, Model # 11161C2, Flexible Neuroscope

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

ALAZCACOCTDEFLGAILINMAMDMIMNMONCNHNJOHORPASCTNTXVAWAWIWV
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
84896
Lot/product code:
All Lots
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2019

Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

ALAZCACOCTDEFLGAILINMAMDMIMNMONCNHNJOHORPASCTNTXVAWAWIWV
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
84896
Lot/product code:
All Lots
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83813
Lot/product code:
1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, J13F0291G, J13F0292G, J13F0300G, M13F0950G, M13F1150G, B23F1313G, M13F0995G, M13F1044G, C23F1699G, J13F0293G, J13F0294G, J13F0295G, J13F0374G, J13F0375G, J13F0378G, J13F0379G, L13F0721G, L13F0729G, L13F0767G, L13F0768G, L13F0769G, M13F1062G, M13F1063G, E23F2068G, M13F1069G, D23F1852G, K13F0415G, K13F0426G, B23F1454G, D23F1971G, D23F1987G, K13F0411G, K13F0387G, L13F0755G, M13F1141G, M13F1142G, J13F0333G, J13F0203G, D23F1936G, M13F0991G, B23F1452G, B23F1509G, D23F1980G, D23F1982G, E23F2064G, J13F0308G, M13F1032G, M13F1034G, M13F1046G, M13F1047G, L13F0669G, A23F1266G, A23F1267G, A23F1297G, C23F1589G, B23F1357G, B23F1358G, M13F1074G, D23F1859G, D23F1933G, F23F2081G, F23F2090G, F23F2091G, F23F2092G, F23F2111G, A23F1263G, B23F1362G, C23F1690G, D23F1877G, D23F1888G, D23F1997G, D23F2014G, J13F0250G, J13F0252G, J13F0255G, K13F0462G, K13F0464G, K13F0518G, K13F0533G, L13F0691G, L13F0692G, L13F0741G, M13F0917G, M13F0927G, M13F0939G, M13F0972G, M13F0973G, M13F0993G, M13F0994G, M13F1033G, M13F1045G, M13F1048G, M13F1051G, M13F1070G, M13F1106G, M13F1107G, M13F1108G, M13F1114G, M13F1146G, D23F1867G, L13F0631G, C23F1809G, D23F1835G, L13F0607G, C23F1777G, J13F0222G, J13F0219G, C23F1800G, C23F1801G, C23F1802G, J13F0072G, B23F1346G, B23F1347G, B23F1348G, D23F1853G, M13F1073G, D23F1854G, D23F1855G, D23F1856G, B23F1516G, B23F1526G, B23F1527G, C23F1649G, C23F1779G, K13F0566G, J13F0245G, M13F0940G, D23F1958G, E23F2079G, E23F2072G, K13F0431G, K13F0432G, K13F0435G, K13F0563G, K13F0564G, K13F0565G, A23F1250G, A23F1257G, B23F1316G, J13F0313G, J13F0314G, J13F0315G, A23F1246G, A23F1249G, C23F1728G, C23F1757G, D23F1994G, M13F1040G, L13F0616G, L13F0861G, J13F0273G, A23F1282G, K13F0475G, C23F1767G, C23F1769G, C23F1770G, C23F1772G, D23F1846G, J13F0367G, J13F0368G, D23F1946G, B23F1510G, B23F1512G, B23F1513G, B23F1517G, B23F1521G, B23F1529G, B23F1530G, B23F1534G, B23F1539G, B23F1544G, C23F1725G, C23F1726G, K13F0524G, L13F0724G, L13F0730G, A23F1196G, A23F1198G, B23F1473G, L13F0809G, L13F0810G, L13F0811G, L13F0813G, L13F0814G, C23F1817G, C23F1818G, D23F1839G, M13F0949G, J13F0048G, J13F0189G, J13F0280G, J13F0281G, J13F0348G, M13F1049G, M13F1050G, C23F1723G, D23F1967G, K13F0402G, K13F0406G, K13F0407G, M13F0969G, M13F0975G, M13F0941G, M13F0948G, J13F0324G, B23F1518G, B23F1538G, M13F1052G, M13F1053G, M13F1066G, M13F1067G, K13F0506G, E23F2030G, B23F1423G, B23F1498G, C23F1750G, C23F1756G, D23F1864G, D23F1879G, D23F1960G, D23F2614G, M13F1130G, M13F1131G, D23F2001G, E23F2069G, M13F0976G, M13F1054G, M13F1136G, M13F1137G, M13F1148G, M13F1149G, A23F1286G, M13F1030G, M13F1031G, B23F1309G, J13F0323G, J13F0271G, L13F0614G, L13F0615G, L13F0663G, M13F0945G, M13F0946G, A23F1294G, B23F1528G, M13F1098G, C23F1786G, A23F1224G, A23F1240G, A23F1269G, B23F1329G, B23F1546G, B23F1547G, D23F1841G, D23F1845G, D23F1848G, D23F1947G, D23F1953G, D23F1954G, D23F1956G, D23F2013G, D23F2016G, D23F2017G, J13F0242G, J43F0481G, L13F0612G, M13F1122G, C23F1585G, L13F0637G, A23F1291G, A23F1293G, C23F1791G, L13F0713G, L13F0714G, L13F0685G, B23F1363G, C23F1789G, C23F1790G, C23F1813G, D23F1926G, D23F1966G, D23F1969G, D23F2000G, D23F2018G, D23F2019G, J13F0026G, J13F0247G, J13F0316G, J13F0317G, J13F0382G, J13F0383G, J13F0384G, K13F0390G, K13F0463G, L13F0753G, L13F0840G, L13F0841G, L13F0842G, M13F1056G, M13F1160G, B23F1372G, D23F1908G, D23F2012G, E23F2031G, L13F0594G, L13F0606G, M13F1110G, M13F1111G, M13F1112G, M13F1113G, M13F1115G, M13F1116G, M13F1117G, M13F1118G, M13F1119G, K13F0465G, K13F0482G, K13F0483G, L13F0596G, L13F0602G, D23F1998G, L13F0772G, M13F1089G, M13F1143G, M13F0928G, F23F2080G, C23F1785G, C23F1795G, D23F1913G, A23F1247G, A23F1248G, A23F1251G, A23F1252G, A23F1253G, B23F1305G, B23F1306G, B23F1314G, B23F1317G, B23F1318G, B23F1320G, B23F1376G, B23F1407G, B23F1408G, B23F1409G, B23F1410G, B23F1457G, B23F1458G, B23F1459G, B23F1460G, B23F1461G, B23F1462G, B23F1463G, B23F1464G, B23F1472G, B23F1474G, B23F1481G, B23F1482G, B23F1491G, B23F1492G, B23F1493G, B23F1494G, C23F1695G, C23F1696G, C23F1697G, C23F1698G… (truncated, 535363 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

Problem with packaging sealing process which affects sterility.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83714
Lot/product code:
Lot Numbers 1240 through 1313. Item numbers:   1. 321151-30C;   2. 331151-30C;   3. 321151-31C;   4. 341151-30C;   5. 321151-31A;   6. 341151-31A;   7. 341151-31B;   8. 331151-31B
Recalling firm:
Pajunk GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot SLC1506X 00643169680005 217427355 SLC1510X 00643169680012 217253572 SLC1510X 00643169680012 217298666 SLC1510X 00643169680012 217387126 SLC1510X 00643169680012 217427354 SLC1510X 00643169680012 217487816 SLC1512X 00643169680029 217218112 SLC1512X 00643169680029 217253582 SLC1512X 00643169680029 217387128 SLC1512X 00643169680029 217487818 SLC1512X 00643169680029 217542634 SLC1512X 00643169680029 217859789 SLC1515X 00643169680036 217246455 SLC1515X 00643169680036 217253577 SLC1515X 00643169680036 217306789 SLC1515X 00643169680036 217415822 SLC1515X 00643169680036 217427365 SLC1515X 00643169680036 217823443 SLC1515X 00643169680036 217859165 SLC1515X 00643169680036 217940024 SLC1520X 00643169680043 217253580 SLC1520X 00643169680043 217306787 SLC1520X 00643169680043 217427359 SLC1520X 00643169680043 217542633 SLC1520X 00643169680043 217646425 SLC1520X 00643169680043 217668582 SLC1520X 00643169680043 217799249 SLC1520X 00643169680043 217859164 SLC2006X 00643169680050 217435326 SLC2006X 00643169680050 217913786 SLC2010X 00643169680067 217253573 SLC2010X 00643169680067 217297545 SLC2010X 00643169680067 217387127 SLC2010X 00643169680067 217427356 SLC2010X 00643169680067 217646867 SLC2010X 00643169680067 217668585 SLC2010X 00643169680067 217676631 SLC2010X 00643169680067 217905820 SLC2012X 00643169680074 217253578 SLC2012X 00643169680074 217298670 SLC2012X 00643169680074 217306788 SLC2012X 00643169680074 217415824 SLC2012X 00643169680074 217434925 SLC2012X 00643169680074 217602539 SLC2012X 00643169680074 217668687 SLC2012X 00643169680074 217799250 SLC2012X 00643169680074 217859791 SLC2012X 00643169680074 217940066 SLC2015X 00643169680081 217218115 SLC2015X 00643169680081 217253574 SLC2015X 00643169680081 217271254 SLC2015X 00643169680081 217298669 SLC2015X 00643169680081 217306223 SLC2015X 00643169680081 217404046 SLC2015X 00643169680081 217418812 SLC2015X 00643169680081 217418907 SLC2015X 00643169680081 217427706 SLC2015X 00643169680081 217435327 SLC2015X 00643169680081 217498815 SLC2015X 00643169680081 217615647 SLC2015X 00643169680081 217646871 SLC2015X 00643169680081 217668584 SLC2015X 00643169680081 217713076 SLC2015X 00643169680081 217721607 SLC2015X 00643169680081 217777612 SLC2015X 00643169680081 217799251 SLC2015X 00643169680081 217884509 SLC2015X 00643169680081 217913790 SLC2020X 00643169680098 217218110 SLC2020X 00643169680098 217246457 SLC2020X 00643169680098 217253575 SLC2020X 00643169680098 217271253 SLC2020X 00643169680098 217298667 SLC2020X 00643169680098 217306220 SLC2020X 00643169680098 217387130 SLC2020X 00643169680098 217404047 SLC2020X 00643169680098 217418908 SLC2020X 00643169680098 217487822 SLC2020X 00643169680098 217498821 SLC2020X 00643169680098 217676628 SLC2020X 00643169680098 217713075 SLC2020X 00643169680098 217727927 SLC2020X 00643169680098 217799252 SLC2020X 00643169680098 217850364 SLC2020X 00643169680098 217905822 SLC2025X 00643169680104 217271251 SLC2025X 00643169680104 217542635 SLC2025X 00643169680104 217905821 SLC2030X 00643169680111 217218119 SLC2030X 00643169680111 217427363 SLC2030X 00643169680111 217602538 SLC2030X 00643169680111 217704778 SLC2030X 00643169680111 217777614 SLC22510X 00643169680135 217487815 SLC22510X 00643169680135 217646423 SLC22515X 00643169680159 217427362 SLC22515X 00643169680159 217646422 SLC22520X 00643169680166 217721606 SLC22520X 00643169680166 217913787 SLC22525X 00643169680173 217415820 SLC22525X 00643169680173 218025488 SLC2506X 00643169680180 217823441 SLC2510X 00643169680197 217218122 SLC2510X 00643169680197 217401003 SLC2510X 00643169680197 217427357 SLC2510X 00643169680197 217693881 SLC2510X 00643169680197 217913792 SLC2510X 00643169680197 218034774 SLC2512X 00643169680203 217271257 SLC2512X 00643169680203 217306225 SLC2512X 00643169680203 217415825 SLC2512X 00643169680203 217434924 SLC2512X 00643169680203 217498822 SLC2512X 00643169680203 217606584 SLC2512X 00643169680203 217695006 SLC2512X 00643169680203 217859787 SLC2512X 00643169680203 217913793 SLC2515X 00643169680210 217253581 SLC2515X 00643169680210 217306786 SLC2515X 00643169680210 217401005 SLC2515X 00643169680210 217418813 SLC2515X 00643169680210 217418906 SLC2515X 00643169680210 217427709 SLC2515X 00643169680210 217487819 SLC2515X 00643169680210 217498813 SLC2515X 00643169680210 217542636 SLC2515X 00643169680210 217602540 SLC2515X 00643169680210 217646866 SLC2515X 00643169680210 217693884 SLC2515X 00643169680210 217859788 SLC2515X 00643169680210 217905823 SLC2515X 00643169680210 218045287 SLC2520X 00643169680227 217271256 SLC2520X 00643169680227 217387129 SLC2520X 00643169680227 217404048 SLC2520X 00643169680227 217418909 SLC2520X 00643169680227 217434922 SLC2520X 00643169680227 217487821 SLC2520X 00643169680227 217498819 SLC2520X 00643169680227 217542632 SLC2520X 00643169680227 217646868 SLC2520X 00643169680227 217695009 SLC2520X 00643169680227 217859162 SLC2520X 00643169680227 217913794 SLC2525X 00643169680234 217218108 SLC2525X 00643169680234 21767558… (truncated, 7598 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot EUP1506X 00643169559813 217238068 EUP1506X 00643169618695 217291131 EUP1506X 00643169559813 217354645 EUP1506X 00643169979475 217473721 EUP1506X 00643169618695 217473914 EUP1506X 00643169979475 217506615 EUP1506X 00643169979475 217576082 EUP1506X 00643169559813 217638054 EUP1506X 00643169559813 217833021 EUP1506X 00643169979475 217876349 EUP1510X 00643169559820 217225186 EUP1510X 00643169559820 217238070 EUP1510X 00643169618633 217262907 EUP1510X 00643169559820 217371289 EUP1510X 00643169979413 217396792 EUP1510X 00643169979413 217451079 EUP1510X 00643169979413 217473910 EUP1510X 00643169618633 217473911 EUP1510X 00643169979413 217518609 EUP1510X 00643169559820 217602408 EUP1510X 00643169559820 217610624 EUP1510X 00643169618633 217630776 EUP1510X 00643169559820 217656465 EUP1510X 00643169618633 217704793 EUP1510X 00643169979413 217704794 EUP1510X 00643169979413 217803293 EUP1510X 00643169559820 217804976 EUP1510X 00643169979413 217817346 EUP1510X 00643169979413 217939845 EUP1510X 00643169979413 217960062 EUP1512X 00643169979338 217282165 EUP1512X 00643169559837 217282749 EUP1512X 00643169559837 217290758 EUP1512X 00643169618558 217291003 EUP1512X 00643169618558 217396342 EUP1512X 00643169979338 217451080 EUP1512X 00643169559837 217518423 EUP1512X 00643169979338 217584296 EUP1512X 00643169618558 217728406 EUP1512X 00643169559837 217791032 EUP1512X 00643169618558 217803295 EUP1512X 00643169979338 217817347 EUP1512X 00643169559837 217833023 EUP1512X 00643169979338 217876348 EUP1515X 00643169618688 217216700 EUP1515X 00643169979468 217216702 EUP1515X 00643169559844 217225187 EUP1515X 00643169979468 217270937 EUP1515X 00643169979468 217291129 EUP1515X 00643169618688 217291133 EUP1515X 00643169559844 217379139 EUP1515X 00643169979468 217387047 EUP1515X 00643169618688 217396791 EUP1515X 00643169979468 217451566 EUP1515X 00643169618688 217518610 EUP1515X 00643169979468 217518611 EUP1515X 00643169979468 217584297 EUP1515X 00643169979468 217601078 EUP1515X 00643169979468 217630784 EUP1515X 00643169559844 217638060 EUP1515X 00643169559844 217727985 EUP1515X 00643169618688 217728244 EUP1515X 00643169618688 217775695 EUP1515X 00643169979468 217777586 EUP1515X 00643169559844 217786006 EUP1515X 00643169618688 217791230 EUP1515X 00643169979468 217960063 EUP1515X 00643169559844 217961583 EUP1520X 00643169559851 217253539 EUP1520X 00643169618923 217270929 EUP1520X 00643169979703 217270933 EUP1520X 00643169559851 217313635 EUP1520X 00643169979703 217339009 EUP1520X 00643169979703 217370779 EUP1520X 00643169979703 217387049 EUP1520X 00643169979703 217427611 EUP1520X 00643169979703 217444053 EUP1520X 00643169979703 217480193 EUP1520X 00643169559851 217488906 EUP1520X 00643169618923 217506621 EUP1520X 00643169979703 217518608 EUP1520X 00643169618923 217518614 EUP1520X 00643169979703 217577127 EUP1520X 00643169618923 217682939 EUP1520X 00643169618923 217775696 EUP1520X 00643169559851 217791033 EUP1520X 00643169559851 217875827 EUP2006X 00643169559868 217290755 EUP2006X 00643169559868 217325279 EUP2006X 00643169979574 217473906 EUP2006X 00643169979574 217506617 EUP2006X 00643169979574 217601073 EUP2006X 00643169559868 217602407 EUP2006X 00643169979574 217616434 EUP2006X 00643169559868 217646822 EUP2006X 00643169979574 217682942 EUP2006X 00643169618794 217721594 EUP2006X 00643169559868 217791029 EUP2006X 00643169559868 217913568 EUP2010X 00643169559875 217313603 EUP2010X 00643169559875 217371290 EUP2010X 00643169559875 217465238 EUP2010X 00643169618862 217490849 EUP2010X 00643169618862 217506623 EUP2010X 00643169559875 217535671 EUP2010X 00643169979642 217542638 EUP2010X 00643169979642 217557954 EUP2010X 00643169979642 217584304 EUP2010X 00643169979642 217602587 EUP2010X 00643169979642 217616444 EUP2010X 00643169559875 217656461 EUP2010X 00643169979642 217682944 EUP2010X 00643169559875 217728347 EUP2010X 00643169979642 217728410 EUP2010X 00643169559875 217860167 EUP2010X 00643169979642 217891539 EUP2012X 00643169979307 217225194 EUP2012X 00643169979307 217246462 EUP2012X 00643169979307 217270930 EUP2012X 00643169979307 217282164 EUP2012X 00643169979307 217291005 EUP2012X 00643169559882 217325272 EUP2012X 00643169618527 217339010 EUP2012X 00643169979307 217339011 EUP2012X 00643169559882 217339173 EUP2012X 00643169559882 217347821 EUP2012X 00643169559882 217379135 EUP2012X 00643169618527 217379610 EUP2012X 00643169979307 217379612 EUP2012X 00643169979307 217387051 EUP2012X 00643169618527 217387053 EUP2012X 00643169559882 217418683 EUP2012X 00643169559882 217465237 EUP2012X 00643169979307 217451567 EUP2012X 00643169559882 217479184 EUP2012X 00643169559882 217518421 EUP2012X 00643169559882 217535675 EUP2012X 00643169979307 217557965 EUP2012X 00643169979307 217584406 EUP2012X 00643169979307 217602590 EUP2012X 00643169979307 217630783 EUP2012X 00643169559882 217646823 EUP2012X 00643169559882 217668159 EUP2012X 00643169979307 217704795 EUP2012X 00643169559882 217713354 EUP2012X 00643169618527 217713408 EUP201… (truncated, 27676 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

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FDA has not published a risk classification for this recall yet.

Recall #:
83692
Lot/product code:
UDI: (01)00858164002244(10) 5.50.00  (01)00858164002268(10) 5.51.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83692
Lot/product code:
UDI (01)00858164002190(10) 5.40.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 6, 2019

MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.

The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.

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FDA has not published a risk classification for this recall yet.

Recall #:
83740
Lot/product code:
14G1
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled September 10, 2019

Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 oz, Size 8 - 10 oz, pack 2X10 lbs; and Sea Mart PREMIUM FROZEN YELLOWFIN TUNA LOINS 5-8 LBS IVP, 30 LBS; Sea Mart GRADE AAA FROZEN YELLOWFIN TUNA SAKU 12-16 IVP, 10 LBS; Sea Mart PREMIUM FROZEN YELLOWFIN TUNA STEAKS 8 OZ IVP, 10 LBS; Sea Mart GRADE AAA TUNA CUBE 0.8 OZ IVP, 10 LBS; and PACIFICA FROZEN SEAFOODS, Tuna Round Steak Size 6 OZ IVP, 20 LBS; Tuna Round Steak Size 8 OZ IVP, 20 LBS; J DELUCA FISH COMPANY, INC. TUNA LOIN CC 5 -8 LBS IVP, 30 LBS; TUNA CUBE SIZE 1 INCH IVP, 10 LBS; TUNA SAKU 10-12 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; and Packaged under the FULL MOON FISH Brand - TUNA LOIN 1-3 LBS IVP, 30 LBS; TUNA LOIN 3 -5 LBS IVP 30 LBS; TUNA LOIN 5- 8 LBS IVP 30 LBS; TUNA STEAK 4 OZ IVP, 10 LBS; TUNA STEAK 6 OZ IVP, 10 LBS; TUNA STEAK 8 OZ IVP, 10 LBS; TUNA SAKU 8 -12 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; FROZEN YELLOWFISH TUNA CUBE 2.8 CM IVP, 10 LBS; and TUNA KING brand - TUNA LOIN 5 -8 LBS IVP, 30 LBS; TUNA MEDALLIONS 2-3 OZ IVP, 10 LBS; TUNA STEAK 4 OZ IVP, 10 LBS; TUNA STEAK 6 OZ IVP, 10 LBS; TUNA STEAK 8 OZ IVP, 10 LBS; TUNA SAKU 12-16 OZ IVP, 10 LBS; and MiCal SEAFOOD Brand: Tuna Loins AAA 3-5LB IVP, 30lb; Tuna Loins AAA 5-8 LB IVP, 30 lb.; Tuna POKE AAA 1.5 cm IVP and 2cm IVP, 10 lb.; Tuna Steaks AAA, 4oz, 6oz, 8oz, 1 oz, 10 lb., IVP and Tuna Steaks AA 4oz, 6oz, 8oz, 10 oz, 10 lb.; Tuna Ground Meat AAA IVP, 10 lb.; Tuna Saku AAA 8-12 OZ IVP, 10 lb., Tuna Saku 12-16 oz IVP, 10lb. .

Elevated histamine levels.

CAFLNJRI
▸Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-0588-2020
Lot/product code:
Tidal Seafood: Lot 1008, with production date 6/25/2019 and expiry date 6/25/2021; and Sea Mart: ALL LOTS WITH PRODUCTION DATES: 019022 019159 019189 AND EXIPRY DATES: 021022, 021159, 021189; and Pacifica Frozen Seafoods: ALL LOT WITH PRODUCTION DATE: 01/04/2019 AND EXIPRY DATE: 01/04/2021; and J DELUCA FISH COMPANY, INC.: ALL LOT WITH PRODUCTION DATE: 07/01/2019 AND EXIPRY DATE: 07/01/2021; Full Moon Fish: ALL LOT WITH PRODUCTION DATES: 09/05/2019 & 21/05/2019 AND EXIPRY DATES: 09/05/2021 & 21/05/2021; and Tuna King: ALL LOT WITH PRODUCTION DATE: 13/06/2019 AND EXIPRY DATE: 13/06/2021; and MiCal Seafood: All Lots with Production Dates 04/01/2019 through 5/31/2019.
Recalling firm:
Truong Phu Xanh Co.,
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

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FDA has not published a risk classification for this recall yet.

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
83610
Lot/product code:
All serial numbers serviced between 10/20/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)