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Recalls affecting Arizona

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

16,936 recalls found

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/virusAnnounced 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/virusAnnounced 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)
UnclassifiedAllergenUndeclaredAnnounced 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/virusAnnounced 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/virusAnnounced 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)
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UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2019

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

ALL 50 STATES
▸Full report

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

Recall #:
84653
Lot/product code:
All units with pump firmware version 0.26 manufactured from 2012 until the present time.
Recalling firm:
Flowonix Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2019

Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

ALL 50 STATES
▸Full report

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

Recall #:
84653
Lot/product code:
All units with pump firmware version 0.26 manufactured from 2012 until the present time.  Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10DZ4A73X 10DZ4A53X 10DZ4A28X 10DZ4A84X 10DZ4A45X 10CZ4B14X 10DZ4A40X 10DZ4A72X 10DZ4A64X 10DZ4A79X 10DZ4A60X 10DZ4A82X 10DZ4A37X 10DZ4B39X 10DZ4A54X 10DZ4A67X 10CZ4B29X 10BZ4A59X 10DZ4A20X 10DZ4A38X 10DZ4B04X 10DZ4A36X 10DZ4A91X 10DZ4B37X 10DZ4B06X 10DZ4A34X 10DZ4A25X 10DZ4B24X 10DZ4B49X 10DZ4B38X 10CZ4A89X 10DZ4B05X 10DZ4A15X 10DZ4A43X 10DZ4B54X 10BZ4A25X 10DZ4A66X 10DZ4B53X 10DZ4A29X 10DZ4A23X 10DZ4B08X 10DZ4A21X 10DZ4B40X 10DZ4A83X 10DZ4A17X 10DZ4A62X 10DZ4B19X 10DZ4B46X 10EZ4A36X 10DZ4B16X 10DZ4A87X 10DZ4B25X 10DZ4B43X 10DZ4B10X 10DZ4B61X 10DZ4B50X 10DZ4B07X 10DZ4B48X 10DZ4B26X 10DZ4B29X 10DZ4A27X 10CZ4B27X 10EZ4A02X 10DZ4B22X 10DZ4B15X 10EZ4A46X 10EZ4A27X 10EZ4A01X 10DZ4A47X 10DZ4A81X 10DZ4A33X 10EZ4A30X 10EZ4A26X 10EZ4A51X 10DZ4B03X 10EZ4A37X 10EZ4A13X 10EZ4A39X 10EZ4A35X 10DZ4B45X 10EZ4A28X 10DZ4A10X 10FZ4A34X 10CZ4B35X 10EZ4A09X 10EZ4A43X 10EZ4A05X 10EZ4A17X 10EZ4A16X 10DZ4B21X 10DZ4A94X 10EZ4A19X 10EZ4A45X 10DZ4A44X 10DZ4A68X 10EZ4A25X 10FZ4A29X 10EZ4A32X 10DZ4A48X 10FZ4A24X 10EZ4A18X 10DZ4B55X 10DZ4A06X 10FZ4A02X 10EZ4A57X 10EZ4A24X 10EZ4A58X 10EZ4A06X 10FZ4A38X 10FZ4A03X 10EZ4A29X 10EZ4A08X 10EZ4A55X 10FZ4A36X 10EZ4A20X 10EZ4A31X 10DZ4B18X 10GZ4A40X 10FZ4A18X 10FZ4A39X 10DZ4B42X 10FZ4A31X 10EZ4A47X 10GZ4A44X 10GZ4A58X 10DZ4B51X 10GZ4A27X 10DZ4B30X 10FZ4A37X 10GZ4A01X 10GZ4A43X 10GZ4A38X 10GZ4A35X 10EZ4A48X 10GZ4A03X 10GZ4A08X 10GZ4A37X 10DZ4B41X 10GZ4A02X 10DZ4B31X 10DZ4A55X 10GZ4A76X 10GZ4A66X 10DZ4B20X 10FZ4A15X 10FZ4A01X 10GZ4A34X 10EZ4A10X 10FZ4A22X 10GZ4A73X 10EZ4A53X 10FZ4A21X 10GZ4A94X 10GZ4A06X 10GZ4A61X 10GZ4A78X 10EZ4A60X 10FZ4A13X 10GZ4A96X 10GZ4A04X 10FZ4A28X 10GZ4A11X 10EZ4A34X 10GZ4A59X 10EZ4A11X 10GZ4A05X 10FZ4A04X 10GZ4A18X 10EZ4A49X 10GZ4A54X 10GZ4A92X 10GZ4A90X 10GZ4A57X 10EZ4A40X 10FZ4A40X 10GZ4A63X 10DZ4A49X 10GZ4A41X 10GZ4A29X 10GZ4A83X 10GZ4B54X 10GZ4A70X 10GZ4A19X 10EZ4A23X 10FZ4A06X 10GZ4A95X 10FZ4A20X 10GZ4A30X 10GZ4A89X 10GZ4A72X 10GZ4A71X 10GZ4A12X 10GZ4B34X 10GZ4B18X 10GZ4A09X 10GZ4B22X 10GZ4A99X 10GZ4A93X 10GZ4A64X 10GZ4A77X 10FZ4A05X 10DZ4A59X 10GZ4A75X 10GZ4A98X 10GZ4B26X 10GZ4A33X 10GZ4B08X 10FZ4A32X 10GZ4B59X 10GZ4B38X 10GZ4B07X 10GZ4B44X 10GZ4B41X 10GZ4A69X 10GZ4A87X 10HZ4A02X 10GZ4B55X 10GZ4B28X 10HZ4A26X 10GZ4A91X 10HZ4A41X 10GZ4B52X 10HZ4A46X 10FZ4A35X 10GZ4B16X 10FZ4A09X 10HZ4A70X 10DZ4A12X 10GZ4B37X 10GZ4A42X 10DZ4B35X 10GZ4A20X 10HZ4A82X 10HZ4A49X 10GZ4A97X 10EZ4A59X 10HZ4A16X 10GZ4A21X 10GZ4A53X 10HZ4A07X 10HZ4A33X 10HZ4A81X 10GZ4B06X 10HZ4A19X 10HZ4A22X 10HZ4A83X 10HZ4A20X 10HZ4A21X 10HZ4A12X 10HZ4A04X 10DZ4B12X 10GZ4A07X 10HZ4A15X 10GZ4B01X 10HZ4A80X 10GZ4A46X 10HZ4A35X 10HZ4A39X 10GZ4B51X 10GZ4B12X 10HZ4A09X 10HZ4A57X 10GZ4B32X 10GZ4B57X 10HZ4A71X 10GZ4B10X 10HZ4A25X 10FZ4A07X 10GZ4B11X 10HZ4A64X 10IZ4B09X 10GZ4A81X 10GZ4B21X 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(truncated, 62563 characters total — see the official FDA record for the full value)
Recalling firm:
Flowonix Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2019

Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

ALL 50 STATES
▸Full report

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

Recall #:
84653
Lot/product code:
All units with pump firmware version 0.26 manufactured from 2012 until the present time.  Serial Numbers 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27 10KW4A47 10JW4A29 10JW4A41 10KW4A122 10JW4A02 10KW4A05 10JW4A25 10KW4A38 10KW4A61 10KW4A11 10KW4A16 10KW4A27 10KW4A08 10KW4A117 10KW4A68 10KW4A99 10KW4A91 10KW4A20 10KW4A53 10KW4A106 10KW4A02 10JW4A20 10KW4A35 10KW4A18 10KW4A101 10AX4A21 10JW4A43 10KW4A73 10KW4A123 10KW4A67 10AX4B27 10KW4A31 10KW4A24 10AX4A37 10KW4A83 10AX4A36 10AX4A22 10AX4A10 10KW4A42 10KW4A119 10AX4B24 10KW4A89 10KW4A71 10KW4A116 10AX4A12 10DX4A79 10DX4A10 10AX4B06 10AX4B09 10DX4A95 10AX4A81 10AX4A98 10KW4A103 10AX4A96 10AX4A95 10AX4B82 10AX4A76 10KW4A48 10HY4C42 10KW4A09 10AX4A88 10DX4A32 10AX4A87 10AX4B92 10GX4B05 10GX4A30 10KW4A104 10AX4A14 10DX4A98 10GX4B21 10AX4A85 10KW4A85 10KW4A06 10AX4A73 10GX4A21 10GX4A09 10DX4A85 10GX4A82 10JW4A31 10GX4A87 10JW4A16 10GX4A85 10KW4A12 10GX4B16 10KW4A43 10GX4A34 10GX4A83 10AX4B78 10GX4B03 10GX4A38 10GX4B08 10KW4A29 10GX4B07 10KW4A30 10GX4A32 10AX4B90 10GX4A70 10AX4B81 10AX4B53 10GX4A92 10KY4A20 10KW4A52 10KW4A39 10GX4A19 10GX4A96 10DX4A21 10KX4A02 10DX4B07 10KX4A12 10KX4A15 10KW4A75 10GX4A99 10KX4A43 10GX4A45 10KX4A40 10KX4A41 10DX4A09 10DX4A74 10DX4A48 10KX4A42 10GX4A97 10GX4A10 10AX4B80 10KX4A59 10JW4A04 10KW4A44 10GX4A73 10KX4A14 10KX4A13 10GX4B15 10KX4A70 10KX4A57 10KX4A74 10KW4A25 10GX4A03 10GX4A63 10GX4A71 10KW4A108 10KX4A85 10KW4A105 10GX4A40 10GX4A14 10DX4A33 10BY4A40 10BY4A51 10BY4A39 10KX4A62 10BY4A25 10BY4A59 10BY4A36 10EY4A53 10KX4A10 10KX4A39 10EY4A27 10KX4A26 10EY4A26 10BY4A60 10EY4A38 10KX4A80 10BY4A57 10EY4A17 10EY4A83 10EY4A03 10BY4A48 10EY4A25 10EY4A29 10EY4A88 10EY4A99 10EY4A59 10EY4A05 10EY4A82 10EY4A19 10EY4A67 10EY4A89 10BY4A52 10KX4A17 10EY4A36 10EY4A58 10EY4A73 10EY4A43 10GX4A12 10KX4A78 10EY4A15 10BY4A34 10GY4A63 10EY4A37 10EY4A98 10KX4A25 10BY4A30 10GY4A16 10EY4A48 10KX4A76 10GY4A11 10GY4A19 10GY4A60 10GY4A55 10GY4A50 10GY4A49 10GY4A54 10BY4A31 10EY4A72 10KX4A11 10GY4A66 10GY4A40 10GY4A18 10EY4A94 10GY4A32 10EY4A13 10EY4A46 10GY4A72 10GY4A20 10GY4A06 10KX4A27 10KX4A08 10GY4A45 10KX4A30 10GY4A25 10KX4A32 10BY4A42 10GY4A15 10HY4B20 10GY4A35 10GY4A12 10GY4A58 10HY4B44 10GY4A23 10HY4B29 10GY4A21 10GY4A31 10GY4A53 10HY4B18 10KX4A29 10GY4A52 10HY4B16 10HY4B42 10HY4A97 10GY4A74 10HY4B48 10GY4A34 10HY4B41 10HY4B03 10EY4A76 10GY4A26 10HY4B23 10HY4B40 10HY4B25 10HY4B37 10HY4B55 10HY4B02 10HY4A85 10HY4B22 10HY4B54 10HY4B07 10HY4B80 10HY4B26 10HY4A78 10HY4C29 10HY4C11 10GY4A52¿ 10GX4B14 10KY4A41 10KX4A71 10GX4B02 10AX4B85 10HY4C03 10HY4B86 10HY4C16 10HY4C46 10HY4C34 10HY4B17 10HY4B65 10HY4B30 10HY4B62 10HY4B56 10HY4C35 10HY4B33 10HY4A81 10HY4C13 10HY4B10 10HY4C07 10HY4C27 10HY4C12 10HY4B96 10HY4B76 10HY4B24 10HY4C08 10HY4C39 10HY4C06 10HY4B83 10HY4C30 10HY4C36 10IY4A46 10HY4C40 10HY4B70 10IY4A29 10HY4C01 10HY4A98 10HY4B08 10IY4A17 10HY4C47 10HY4C32 10HY4C26 10IY4A38 10IY4A25 10HY4A80 10IY4A37 10IY4A43 10HY4C41 10IY4A51 10IY4A19 10IY4A33 10HY4B91 10HY4B51 10JY4A10 10KY4A60 10KY4A93 10KY4A15 10JY4A15 10KY4A21 10IY4A27 10IY4A13 10JY4A18 10JY4A07 10KY4A71 10KY4A39 10KY4A06 10HY4B97 10KY4A72 10KY4A86 10IY4A54 10KY4A87 10KY4A31 10AZ4A51 10KY4A25 10IY4A28 10KY4A50 10AZ4A35 10AZ4A24 10KY4A91 10AZ4A57 10IY4A31 10KY4A78 10KY4A84 10KY4A03 10KY4A82 10KY4A62 10KY4A44 10KY4A13 10HY4A79 10KY4A69 10AZ4A15 10JY4A28 10KY4A51 10JY4A16 10KY4A36 10AZ4A14 10AZ4A65 10KY4A94 10KY4A64 10KY4A47 10KY4A67 10JY4A03 10HY4A91 10AZ4A54 10HY4C23 10AZ4A08 10KY4A40 10AZ4A31 10BZ4A26 10KY4A79 10IY4A04 10EY4A60 10HY4B90 10KY4A90 10EY4A40 10KY4A30 10IY4A02 10AZ4A22
Recalling firm:
Flowonix Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo 924 Safety Screw Spike Set, Product Code 775759

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 26, 2019

Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD

The feeding spike sets may leak at the interface of the tube and spike connector.

ALL 50 STATES
▸Full report

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

Recall #:
84656
Lot/product code:
All
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2020

Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

Sterile drapes packaged in an unsealed pouch.

ALL 50 STATES
▸Full report

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

Recall #:
85474
Lot/product code:
Impacted Lot Numbers for HH2000 - 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061, 1704071, 1704081, 1704091, 1704101, 1704111, 1704121, 1704131, 1704141, 1704151, 1704161, 1704171, 1704181, 1704191, 1704201, 1704211, 1704221, 1704231, 1704241, 1704251, 1704261, 1704271, 1704281, 1704291, 1704301, 1705011, 1705021, 1705031, 1705041, 1705051, 1705061, 1705071, 1705081, 1705091, 1705101, 1705111, 1705121, 1705131, 1705141, 1705151, 1705161, 1705171, 1705181, 1705191, 1705201, 1705211, 1705221, 1705231, 1705241, 1705251, 1705261, 1705271, 1705281, 1705291, 1705301, 1705311, 1706011, 1706021, 1706031, 1706041, 1706051, 1706061, 1706071, 1706081, 1706091, 1706101, 1706111, 1706121, 1706131, 1706141, 1706151, 1706161, 1706171, 1706181, 1706191, 1706201, 1706211, 1706221, 1706231, 1706241, 1706251, 1706261, 1706271, 1706281, 1706291, 1706301, 1707011, 1707021, 1707031, 1707041, 1707051, 1707061, 1707071, 1707081, 1707091, 1707101, 1707111, 1707121, 1707131, 1707141, 1707151, 1707161, 1707171, 1707181, 1707191, 1707201, 1707211, 1707221, 1708221, 1709221, 1710191, 1710201, 1710211, 1710221, 1711191, 1711201, 1711211, 1711221, 1711231, 1712021, 1712041, 1712051, 1712061, 1712071, 1712081, 1712091, 1712111, 1712121, 1712131, 1712141, 1712151, 1712161, 1712181, 1712271, 1712281, 1712291, 1712301, 1801031, 1801111, 1805251, 1805261, 1805271, 1805281, 1805291, 1805301, 1805311, 1806011, 1806021, 1806041, 1806051, 1806061, 1806071, 1806091, 1806111, 1806201, 1806211, 1807031, 1807061, 1807071, 1807091, 1807251, 1807261, 1807271, 1808171, 1808181, 1808201, 1808221, 1808231, 1808241, 1808301, 1808311, 1809011, 1809021, 1809031, 1810041, 1810051, 1810061, 1812051, 1812151, 1902231, 1902241, 1902251, 1902261, 1902271, 1902281, 1903011, 1903021, 1903031, 1903181, 1903191, 1903201, 1903211, 1903221, 1903271, 1903281, 1904231, 1904241, 1904251, 1904291, 1905141, 1905151, 1905161, 1905171, 1905211, 1905221, 1905231, 1905241, 1905251, 1906241, 1906251, 1906271, 1906281, 1906291, 1907011, 1907221, 1907231, 1907241, 1907251, 1907261, 1907271, 1907311, 1908011, 1908021, 1908031, 1908051, 1908061, 1908071, 1908081, 1908091, 1908151  HH9006 Spy-Phi Pack Impacted Lot Numbers - 1701x, 1702x, 1703x, 1704x, 1705x, 1706x, 1707x, 1708x, 1709x, 1710x, 1711x, 1712x, 1801x, 1802x, 1803x, 1804x, 1805x, 1806x, 1807x, 1808x, 1809x, 1810x, 1811x, 1812x, 1901x, 1902x, 1903x, 1904x, 1905x, 1906x, 1907x, 1908x, 1909x, 19103. Where x is any alpha numeric character.
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2020

Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

Sterile drapes packaged in an unsealed pouch.

ALL 50 STATES
▸Full report

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

Recall #:
85474
Lot/product code:
Impacted Lot Numbers - 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061, 1704071, 1704081, 1704091, 1704101, 1704111, 1704121, 1704131, 1704141, 1704151, 1704161, 1704171, 1704181, 1704191, 1704201, 1704211, 1704221, 1704231, 1704241, 1704251, 1704261, 1704271, 1704281, 1704291, 1704301, 1705011, 1705021, 1705031, 1705041, 1705051, 1705061, 1705071, 1705081, 1705091, 1705101, 1705111, 1705121, 1705131, 1705141, 1705151, 1705161, 1705171, 1705181, 1705191, 1705201, 1705211, 1705221, 1705231, 1705241, 1705251, 1705261, 1705271, 1705281, 1705291, 1705301, 1705311, 1706011, 1706021, 1706031, 1706041, 1706051, 1706061, 1706071, 1706081, 1706091, 1706101, 1706111, 1706121, 1706131, 1706141, 1706151, 1706161, 1706171, 1706181, 1706191, 1706201, 1706211, 1706221, 1706231, 1706241, 1706251, 1706261, 1706271, 1706281, 1706291, 1706301, 1707011, 1707021, 1707031, 1707041, 1707051, 1707061, 1707071, 1707081, 1707091, 1707101, 1707111, 1707121, 1707131, 1707141, 1707151, 1707161, 1707171, 1707181, 1707191, 1707201, 1707211, 1707221, 1708221, 1709221, 1710191, 1710201, 1710211, 1710221, 1711191, 1711201, 1711211, 1711221, 1711231, 1712021, 1712041, 1712051, 1712061, 1712071, 1712081, 1712091, 1712111, 1712121, 1712131, 1712141, 1712151, 1712161, 1712181, 1712271, 1712281, 1712291, 1712301, 1801031, 1801111, 1805251, 1805261, 1805271, 1805281, 1805291, 1805301, 1805311, 1806011, 1806021, 1806041, 1806051, 1806061, 1806071, 1806091, 1806111, 1806201, 1806211, 1807031, 1807061, 1807071, 1807091, 1807251, 1807261, 1807271, 1808171, 1808181, 1808201, 1808221, 1808231, 1808241, 1808301, 1808311, 1809011, 1809021, 1809031, 1810041, 1810051, 1810061, 1812051, 1812151, 1902231, 1902241, 1902251, 1902261, 1902271, 1902281, 1903011, 1903021, 1903031, 1903181, 1903191, 1903201, 1903211, 1903221, 1903271, 1903281, 1904231, 1904241, 1904251, 1904291, 1905141, 1905151, 1905161, 1905171, 1905211, 1905221, 1905231, 1905241, 1905251, 1906241, 1906251, 1906271, 1906281, 1906291, 1907011, 1907221, 1907231, 1907241, 1907251, 1907261, 1907271, 1907311, 1908011, 1908021, 1908031, 1908051, 1908061, 1908071, 1908081, 1908091, 1908151
Recalling firm:
Stryker Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 12, 2020

Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

ALL 50 STATES
▸Full report

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

Recall #:
84788
Lot/product code:
Lots N1521417 N1522218 N1528917 N1526418 N1502518 N1527518 N1503218 N1529618 N1503918 N1530318 N1504618 N1531018 N1516318 N1531618 N1517218 N1532318 N1518318 N1535518 N1519418 N1536318 N1520118   ***new lots added 3/2/2020***  N1500119 N1520519  N1500219 N1521319  N1500620 N1522419  N1501119 N1523319  N1501520 N1526719  N1503519 N1527619  N1505619 N1528719  N1506419 N1529619  N1507919 N1533819  N1508519 N1534719  N1510619 N1535719  N1519019 N1530419  N1519719
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled January 12, 2020

Granulate Pure Cane Sugar sold under the brand names of: Ahold 16 oz canister, DISTRIBUTED BY FOODHOLD USA, LLC, LANDOVER, MD 20758 UPC 6 88267 08529 1; N'Joy 22 oz canister, SUGAR FOODS CORPORATION NEW YORK, NY 10022, UPC 0 86631 00698 7; Speedway 22oz canister, DISTRIBUTED BY: SUGAR FOODS CORPORATION NEW YORK, NY 10022, No UPC

They were notified by their supplier that the product may be contaminated with foreign material.

ALAZCACTFLGAILINKSMDMINCNJNYOHPATX
▸Full report

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

Recall #:
F-0736-2020
Lot/product code:
Ahold Sugar: 90257, Lot number 0400103 BEST BY JAN03 2022B04 N'Joy Pure Sugar: 90707, Lot number 0400103, BEST BY JAN03 2022B04, 90708, Lot number 0400103, BEST BY JAN03 2022B04, 90708, Lot number 0400106, BEST BY JAN06 2022B04, 90708, Lot number 0400107, BEST BY JAN07 2022B04, & 90698, Lot number 0400103, BEST BY JAN03 2022B04. Speedway Sugar: 90581, Lot number 0400108 03A
Recalling firm:
Sugar Foods Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2020

Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.

Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

ALL 50 STATES
▸Full report

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

Recall #:
84837
Lot/product code:
GTIN: 00643169707573
Recalling firm:
Medtronic CoreValve LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 14, 2020

Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.

Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

ALL 50 STATES
▸Full report

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

Recall #:
84837
Lot/product code:
GTIN: 00643169707535
Recalling firm:
Medtronic CoreValve LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 15, 2020

BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

ALL 50 STATES
▸Full report

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

Recall #:
85476
Lot/product code:
Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2020

HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

ALL 50 STATES
▸Full report

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

Recall #:
84829
Lot/product code:
Model Number: 1640, all Serial Numbers.   Known Model Numbers (Serial Numbers) GTIN Numbers: 1640CA (BAC004576) 00888707001298,  1640GB (BAC004765) 00888707001328,  1640GB (BAC004768) 00888707001328,  1640AR (BAC004772) 00888707001274,  1640IN (BAC004829) 00888707000543,  1640DE (BAC005530) 00888707001304,  1640CA (BAC005842) 00888707001298,  1640CA (BAC005854) 00888707001298,  1640BR (BAC005875) 00888707001281,  1640BR (BAC005876) 00888707001281,  1640GB (BAC005920) 00888707001328,  1640AU (BAC005966) 00888707001267,  1640AU (BAC005980) 00888707001267,  1640IN (BAC005997) 00888707000543,  1640AU (BAC006001) 00888707001267,  1640IL (BAC006027) 00888707001335,  1640IT (BAC006032) 00888707001342,  1640IN (BAC006033) 00888707000543,  1640IN (BAC006034) 00888707000543,  1640IN (BAC006035) 00888707000543,  1640IN (BAC006036) 00888707000543,  1640IL (BAC006037) 00888707001335,  1640IL (BAC006038) 00888707001335,  1640GB (BAC006039) 00888707001328,  1640DE (BAC006040) 00888707001304,  1640DE (BAC006041) 00888707001304,  1640DE (BAC006056) 00888707001304,  1640CA (BAC006087) 00888707001298,  1640IN (BAC006102) 00888707000543,  1640IN (BAC006104) 00888707000543,  1640DE (BAC090005) 00888707002325,  1640CH (BAC090006) 00888707002318,  1640CH (BAC090012) 00888707002318,  1640GB (BAC090079) 00888707002332,  1640IT (BAC090082) 00888707002363,  1640IT (BAC090083) 00888707002363,  1640GB (BAC090084) 00888707002332,  1640CH (BAC090165) 00888707002318,  1640CH (BAC090166) 00888707002318,  1640DE (BAC090167) 00888707002325,  1640DE (BAC090168) 00888707002325,  1640DE (BAC090170) 00888707002325,  1640GB (BAC090171) 00888707002332,  1640GB (BAC090172) 00888707002332,  1640IT (BAC090173) 00888707002363,  1640IT (BAC090174) 00888707002363,  1640DE (BAC090175) 00888707002325,  1640IN (BAC090237) 00888707002356,  1640IN (BAC090238) 00888707002356,  1640DE (BAC090414) 00888707002325,  1640DE (BAC090415) 00888707002325,  1640DE (BAC090416) 00888707002325,  1640DE (BAC090417) 00888707002325,  1640DE (BAC090447) 00888707002325,  1640DE (BAC090448) 00888707002325,  1640IT (BAC090611) 00888707002363,  1640AU (BAC090659) 00888707002288,  1640AU (BAC090660) 00888707002288,  1640CA (bac090661) 00888707002301,  1640CA (BAC090662) 00888707002301,  1640GB (BAC090663) 00888707002332,  1640GB (BAC090664) 00888707002332,  1640IT (BAC090665) 00888707002363,  1640DE (BAC090666) 00888707002325,  1640DE (BAC090667) 00888707002325,  1640AU (BAC090732) 00888707002288,  1640AU (bac090733) 00888707002288,  1640GB (BAC090734) 00888707002332,  1640GB (BAC090735) 00888707002332,  1640DE (BAC090864) 00888707002325,  1640DE (BAC090976) 00888707002325,  1640DE (BAC091324) 00888707003018,  1640DE (BAC091325) 00888707003018,  1640DE (BAC091326) 00888707003018,  1640DE (BAC091327) 00888707003018,  1640DE (BAC091330) 00888707003018,  1640DE (BAC091331) 00888707003018,  1640DE (BAC091332) 00888707003018,  1640DE (BAC091333) 00888707003018,  1640DE (BAC091420) 00888707003018,  1640DE (BAC091421) 00888707003018,  1640CA (BAC091690) 00888707003056,  1640CA (BAC091691) 00888707003056,  1640DE (BAC091695) 00888707003018,  1640DE (BAC091696) 00888707003018,  1640DE (BAC091697) 00888707003018,  1640DE (BAC091698) 00888707003018,  1640DE (BAC091699) 00888707003018,  1640DE (BAC091700) 00888707003018,  1640DE (BAC091701) 00888707003018,  1640DE (BAC091702) 00888707003018,  1640DE (BAC091703) 00888707003018,  1640DE (BAC091704) 00888707003018,  1640GB (BAC091738) 00888707003025,  1640GB (BAC091739) 00888707003025,  1640DE (BAC091741) 00888707003018,  1640GB (BAC091743) 00888707003025,  1640GB (BAC091744) 00888707003025,  1640DE (BAC091758) 00888707003018,  1640DE (BAC091811) 00888707003018,  1640DE (BAC091812) 00888707003018,  1640DE (BAC092205) 00888707003018,  1640DE (BAC092206) 00888707003018,  1640IT (BAC092283) 00888707003032,  1640GB (BAC092289) 00888707003025,  1640JP (BAC092290) 00888707002370,  1640JP (BAC092292) 00888707002370,  1640CA (BAC092294) 00888707003056,  1640DE (BAC092332) 00888707003018,  1640DE (BAC092333) 00888707003018,  1640DE (BAC092334) 00888707003018,  1640DE (BAC092335) 00888707003018,  1640DE (BAC092391) 00888707003018,  1640IN (BAC092396) 00888707003049,  1640JP (BAC092459) 00888707002370,  1640DE (BAC092495) 00888707003018,  1640DE (BAC092506) 00888707003018,  1640DE (BAC092556) 00888707003018,  1640DE (BAC092557) 00888707003018,  1640DE (BAC092558) 00888707003018,  1640DE (BAC092559) 00888707003018,  1640DE (BAC092560) 00888707003018,  1640JP (BAC092595) 00888707002370,  1640JP (BAC092680) 00888707002370,  1640JP (BAC092681) 00888707002370,  1640JP (BAC092682) 00888707002370,  1640JP (BAC092683) 00888707002370,  1640JP (BAC092684) 00888707002370,  1640JP (BAC092685) 00888707002370,  1640JP (BAC092687) 00888707002370,  1640JP (BAC092689) 00888707002370,  1640JP (BAC092690) 00888707002370,  1640GB (BAC092748) 00888707003025,  1640GB (BAC092752) 00888707003025,  1640DE (BAC092760) 00888707003018,  1640IN (BAC100001) 00888707005913,  1640IN (BA… (truncated, 12207 characters total — see the official FDA record for the full value)
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 23, 2020

HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

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▸Full report

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

Recall #:
84829
Lot/product code:
Model Number: 1610, all Serial Numbers.   Known Model Numbers (Serial Numbers) GTIN Numbers: 1610GB (BCH000001) 00888707002219,  1610GB (BCH000002) 00888707002219,  1610DE (BCH000003) 00888707002202,  1610DE (BCH000004) 00888707002202,  1610IT (BCH000005) 00888707002240,  1610IT (BCH000006) 00888707002240,  1610DE (BCH000007) 00888707002202,  1610DE (BCH000008) 00888707002202,  1610CH (BCH000010) 00888707002196,  1610DE (BCH000011) 00888707002202,  1610DE (BCH000012) 00888707002202,  1610CH (BCH000013) 00888707002196,  1610IT (BCH000014) 00888707002240,  1610DE (BCH000015) 00888707002202,  1610DE (BCH000017) 00888707002202,  1610DE (BCH000018) 00888707002202,  1610DE (BCH000019) 00888707002202,  1610IT (BCH000020) 00888707002240,  1610DE (BCH000021) 00888707002202,  1610GB (BCH000022) 00888707002219,  1610GB (BCH000023) 00888707002219,  1610DE (BCH000024) 00888707002202,  1610IT (BCH000025) 00888707002240,  1610IT (BCH000026) 00888707002240,  1610IT (BCH000027) 00888707002240,  1610DE (BCH000028) 00888707002202,  1610CH (BCH000029) 00888707002196,  1610CH (BCH000030) 00888707002196,  1610DE (BCH000031) 00888707002202,  1610DE (BCH000032) 00888707002202,  1610DE (BCH000033) 00888707002202,  1610DE (BCH000034) 00888707002202,  1610GB (BCH000035) 00888707002219,  1610DE (BCH000036) 00888707002202,  1610GB (BCH000037) 00888707002219,  1610CH (BCH000038) 00888707002196,  1610CH (BCH000039) 00888707002196,  1610DE (BCH000040) 00888707002202,  1610GB (BCH000041) 00888707002219,  1610CH (BCH000042) 00888707002196,  1610GB (BCH000043) 00888707002219,  1610GB (BCH000044) 00888707002219,  1610GB (BCH000045) 00888707002219,  1610IT (BCH000047) 00888707002240,  1610DE (BCH000048) 00888707002202,  1610GB (BCH000050) 00888707002219,  1610DE (BCH000051) 00888707002202,  1610DE (BCH000052) 00888707002202,  1610DE (BCH000053) 00888707002202,  1610GB (BCH000054) 00888707002219,  1610GB (BCH000055) 00888707002219,  1610GB (BCH000056) 00888707002219,  1610DE (BCH000057) 00888707002202,  1610IT (BCH000058) 00888707002240,  1610DE (BCH000059) 00888707002202,  1610DE (BCH000061) 00888707002202,  1610CH (BCH000063) 00888707002196,  1610DE (BCH000064) 00888707002202,  1610DE (BCH000065) 00888707002202,  1610GB (BCH000066) 00888707002219,  1610IT (BCH000067) 00888707002240,  1610CH (BCH000068) 00888707002196,  1610AU (BCH000069) 00888707002165,  1610DE (BCH000071) 00888707002202,  1610GB (BCH000072) 00888707002219,  1610DE (BCH000073) 00888707002202,  1610GB (BCH000074) 00888707002219,  1610GB (BCH000076) 00888707002219,  1610DE (BCH000077) 00888707002202,  1610GB (BCH000078) 00888707002219,  1610DE (BCH000079) 00888707002202,  1610GB (BCH000080) 00888707002219,  1610IT (BCH000081) 00888707002240,  1610CH (BCH000082) 00888707002196,  1610DE (BCH000083) 00888707002202,  1610GB (BCH000084) 00888707002219,  1610DE (BCH000085) 00888707002202,  1610DE (BCH000086) 00888707002202,  1610DE (BCH000087) 00888707002202,  1610DE (BCH000088) 00888707002202,  1610DE (BCH000089) 00888707002202,  1610IT (BCH000090) 00888707002981,  1610CH (BCH000091) 00888707002196,  1610JP (BCH000092) 00888707002257,  1610DE (BCH000093) 00888707002202,  1610CH (BCH000094) 00888707002196,  1610DE (BCH000095) 00888707002202,  1610DE (BCH000096) 00888707002202,  1610CH (BCH000097) 00888707002196,  1610GB (BCH000098) 00888707002219,  1610GB (BCH000099) 00888707002219,  1610CH (BCH000100) 00888707002196,  1610DE (BCH000101) 00888707002202,  1610DE (BCH000102) 00888707002202,  1610DE (BCH000103) 00888707002202,  1610DE (BCH000104) 00888707002202,  1610DE (BCH000105) 00888707002202,  1610DE (BCH000106) 00888707002202,  1610DE (BCH000107) 00888707002202,  1610DE (BCH000108) 00888707002202,  1610DE (BCH000109) 00888707002202,  1610DE (BCH000110) 00888707002202,  1610DE (BCH000111) 00888707002202,  1610DE (BCH000112) 00888707002202,  1610DE (BCH000113) 00888707002202,  1610DE (BCH000114) 00888707002202,  1610DE (BCH000115) 00888707002202,  1610DE (BCH000116) 00888707002202,  1610DE (BCH000117) 00888707002202,  1610DE (BCH000118) 00888707002202,  1610DE (BCH000119) 00888707002202,  1610DE (BCH000120) 00888707002202,  1610DE (BCH000121) 00888707002202,  1610DE (BCH000122) 00888707002202,  1610DE (BCH000123) 00888707002202,  1610DE (BCH000124) 00888707002202,  1610DE (BCH000125) 00888707002202,  1610DE (BCH000126) 00888707002202,  1610DE (BCH000127) 00888707002202,  1610DE (BCH000128) 00888707002202,  1610DE (BCH000129) 00888707002202,  1610DE (BCH000130) 00888707002202,  1610DE (BCH000131) 00888707002202,  1610DE (BCH000132) 00888707002202,  1610DE (BCH000134) 00888707002202,  1610DE (BCH000135) 00888707002202,  1610DE (BCH000136) 00888707002202,  1610DE (BCH000138) 00888707002202,  1610DE (BCH000139) 00888707002202,  1610DE (BCH000140) 00888707002202,  1610DE (BCH000141) 00888707002202,  1610DE (BCH000142) 00888707002202,  1610DE (BCH000143) 00888707002202,  1610DE (BCH000144) 00888707002202,  1610DE (BCH000145) 00888707002202,  1610DE (BCH000146) 00888707002202,  1610DE (BC… (truncated, 209397 characters total — see the official FDA record for the full value)
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2020

fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once

FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.

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

Recall #:
84707
Lot/product code:
All Lots
Recalling firm:
Fridababy LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2020

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.

These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.

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

Recall #:
84961
Lot/product code:
Catalog no: 02-012-64-1812  Serial number: 6366405, 6367075, 6367076
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 28, 2020

McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

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

Recall #:
84819
Lot/product code:
UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121
Recalling firm:
Medtronic, PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 29, 2020

Class IV New Era medical laser device

The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

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▸Full report

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

Recall #:
86706
Lot/product code:
New Era laser units
Recalling firm:
Inova Lasers LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 30, 2020

Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

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▸Full report

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

Recall #:
84944
Lot/product code:
Product Number 29901; All Serial Numbers;   Known Model Numbers:  a. Model Number 29901, GTIN (Lot Numbers): 00643169369030 (JVD000243P),  00643169369030 (JVD000246P),  00643169369030 (JVD000248P),  00643169369030 (JVD000249P),  00643169369030 (JVD000250P),  00643169369030 (JVD000252P),  00643169369030 (JVD000270P),  00643169369030 (JVD000274P),  00643169369030 (JVD000277P),  00643169369030 (JVD000280P),  00643169369030 (JVD000281P),  00643169369030 (JVD000302P),  00643169369030 (JVD000303P),  00643169167087 (JVD000304P),  00643169369030 (JVD000312P),  00643169369030 (JVD000315P),  00643169167087 (JVD000317P),  00643169369030 (JVD000323P),  00643169369030 (JVD000325P),  00643169369030 (JVD000327P),  00643169369030 (JVD000328P),  00643169369030 (JVD000329P),  00643169369030 (JVD000335P),  00643169369030 (JVD000340P),  00643169369030 (JVD000345P),  00643169369030 (JVD000349P),  00643169369030 (JVD000365P),  00643169369030 (JVD000366P),  00643169369030 (JVD000375P),  00643169369030 (JVD000380P),  00643169369030 (JVD000396P),  00643169369030 (JVD000400P),  00643169369030 (JVD000403P),  00643169369030 (JVD000406P),  00643169369030 (JVD000416P),  00643169369030 (JVD000422P),  00643169369030 (JVD000423P),  00643169369030 (JVD000427P),  00643169369030 (JVD000429P),  00643169369030 (JVD000431P),  00643169369030 (JVD000433P),  00643169369030 (JVD000435P),  00643169369030 (JVD000436P),  00643169369030 (JVD000438P),  00643169369030 (JVD000440P),  00643169369030 (JVD000441P),  00643169369030 (JVD000442P),  00643169369030 (JVD000443P),  00643169369030 (JVD000456P),  00643169369030 (JVD000462P),  00643169225732 (JVD000463P),  00643169369030 (JVD000464P),  00643169369030 (JVD000465P),  00643169369030 (JVD000466P),  00643169369030 (JVD000467P),  00643169369030 (JVD000468P),  00643169369030 (JVD000469P),  00643169369030 (JVD000470P),  00643169369030 (JVD000472P),  00643169225732 (JVD000473P),  00643169225732 (JVD000474P),  00643169369030 (JVD000475P),  00643169369030 (JVD000477P),  00643169369030 (JVD000483P),  00643169225732 (JVD000484P),  00643169369030 (JVD000485P),  00643169369030 (JVD000486P),  00643169225732 (JVD000489P),  00643169369030 (JVD000490P),  00643169369030 (JVD000491P),  00643169369030 (JVD000492P),  00643169369030 (JVD000494P),  00643169369030 (JVD000495P),  00643169369030 (JVD000496P),  00643169369030 (JVD000498P),  00643169369030 (JVD000499P),  00643169369030 (JVD000500P),  00643169225732 (JVD000501P),  00643169369030 (JVD000502P),  00643169369030 (JVD000503P),  00643169369030 (JVD000505P),  00643169369030 (JVD000506P),  00643169369030 (JVD000507P),  00643169369030 (JVD000508P),  00643169369030 (JVD000509P),  00643169369030 (JVD000510P),  00643169369030 (JVD000512P),  00643169369030 (JVD000513P),  00643169369030 (JVD000514P),  00643169369030 (JVD000515P),  00643169369030 (JVD000516P),  00643169369030 (JVD000517P),  00643169369030 (JVD000520P),  00643169225732 (JVD000523P),  00643169369030 (JVD000524P),  00643169225732 (JVD000525P),  00643169369030 (JVD000526P),  00643169369030 (JVD000531P),  00643169369030 (JVD000532P),  00643169369030 (JVD001001P),  00643169225732 (JVD001002P),  00643169369030 (JVD001003P),  00643169369030 (JVD001005P),  00643169369030 (JVD001006P),  00643169369030 (JVD001007P),  00643169225732 (JVD001008P),  00643169369030 (JVD001009P),  00643169369030 (JVD001011P),  00643169369030 (JVD001013P),  00643169225732 (JVD001016P),  00643169369030 (JVD001017P),  00643169369030 (JVD001018P),  00643169369030 (JVD001019P),  00643169369030 (JVD001020P),  00643169369030 (JVD001021P),  00643169369030 (JVD001022P),  00643169369030 (JVD001023P),  00643169369030 (JVD001025P),  00643169369030 (JVD001030P),  00643169167087 (JVD001031P),  00643169369030 (JVD001033P),  00643169369030 (JVD001034P),  00643169369030 (JVD001035P),  00643169369030 (JVD001036P),  00643169369030 (JVD001037P),  00643169369030 (JVD001039P),  00643169369030 (JVD001040P),  00643169369030 (JVD001041P),  00643169369030 (JVD001042P),  00643169369030 (JVD001043P),  00643169369030 (JVD001044P),  00643169369030 (JVD001045P),  00643169369030 (JVD001046P),  00643169369030 (JVD001047P),  00643169369030 (JVD001048P),  00643169369030 (JVD001049P),  00643169369030 (JVD001050P),  00643169369030 (JVD001051P),  00643169369030 (JVD001052P),  00643169369030 (JVD001053P),  00643169369030 (JVD001054P),  00643169369030 (JVD001055P),  00643169369030 (JVD001056P),  00643169369030 (JVD001058P),  00643169369030 (JVD001059P),  00643169369030 (JVD001060P),  00643169369030 (JVD001061P),  00643169225732 (JVD001063P),  00643169225732 (JVD001064P),  00643169225732 (JVD001065P),  00643169369030 (JVD001066P),  00643169225732 (JVD001067P),  00643169369030 (JVD001070P),  00643169369030 (JVD001071P),  00643169369030 (JVD001072P),  00643169369030 (JVD001073P),  00643169369030 (JVD001074P),  00643169369030 (JVD001075P),  00643169369030 (JVD001076P),  00643169369030 (JVD001077P),  00643169369030 (JVD001078P),  00643169369030 (JVD001079P),  00643169369030 (JVD001080P), … (truncated, 166353 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 30, 2020

Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

ALL 50 STATES
▸Full report

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

Recall #:
84944
Lot/product code:
Product Number 2090; All Serial Numbers;   Known Model Numbers:  a. Model Number 2090, GTIN (Lot Numbers): 00721902546341 (PKK002840R),  00721902246234 (PKK012608R),  00721902246234 (PKK013358R),  00721902569517 (PKK017436R),  00613994580955 (PKK204009R),  00643169537828 (PKK001072R),  00613994175397 (PKK001076R),  00613994175397 (PKK001135R),  00613994175397 (PKK001172R),  00613994175120 (PKK001321R),  00613994175106 (PKK001322R),  00721902246234 (PKK001324R),  00721902246227 (PKK001327R),  00613994175212 (PKK001328R),  00613994175106 (PKK001331R),  00643169537828 (PKK001332R),  00721902246234 (PKK001335R),  00613994175144 (PKK001348R),  00721902246227 (PKK001352R),  00613994175076 (PKK001358R),  00613994581075 (PKK001359R),  00721902246234 (PKK001361R),  00643169537828 (PKK001362R),  00613994175397 (PKK001364R),  00613994581204 (PKK001367R),  00613994175267 (PKK001373R),  00613994175397 (PKK001376R),  00613994175120 (PKK001382R),  00613994175397 (PKK001386R),  00613994175083 (PKK001387R),  00643169537828 (PKK001390R),  00613994175397 (PKK001395R),  00613994581235 (PKK001398R),  00613994175106 (PKK001400R),  00721902246234 (PKK001401R),  00613994175212 (PKK001403R),  00613994175106 (PKK001407R),  00613994136534 (PKK001409R),  00613994175120 (PKK001410R),  00613994581235 (PKK001411R),  00613994581228 (PKK001420R),  00613994136527 (PKK001421R),  00613994136527 (PKK001422R),  00613994175120 (PKK001425R),  00613994175182 (PKK001431R),  00643169440166 (PKK001433R),  00613994175076 (PKK001437R),  00613994175083 (PKK001444R),  00613994175076 (PKK001448R),  00613994581228 (PKK001454R),  00613994175380 (PKK001459R),  00613994175380 (PKK001460R),  00613994175090 (PKK001473R),  00613994175083 (PKK001474R),  00613994175106 (PKK001476R),  00613994136527 (PKK001480R),  00613994581075 (PKK001484R),  00613994175212 (PKK001485R),  00613994175120 (PKK001487R),  00613994175106 (PKK001488R),  00613994175397 (PKK001489R),  00613994175212 (PKK001490R),  00613994175106 (PKK001494R),  00721902246241 (PKK001496R),  00613994175076 (PKK001497R),  00721902246227 (PKK001503R),  00643169537828 (PKK001506R),  00613994175083 (PKK001510R),  00613994581235 (PKK001511R),  00721902246241 (PKK001519R),  00613994581013 (PKK001520R),  00613994175120 (PKK001524R),  00613994175212 (PKK001525R),  00613994581235 (PKK001531R),  00721902246234 (PKK001532R),  00613994175106 (PKK001533R),  00721902246234 (PKK001539R),  00721902246234 (PKK001541R),  00613994136527 (PKK001542R),  00613994581594 (PKK001550R),  00721902246234 (PKK001551R),  00613994581013 (PKK001555R),  00613994175397 (PKK001556R),  00613994581075 (PKK001561R),  00721902246234 (PKK001562R),  00613994136527 (PKK001563R),  00613994175120 (PKK001568R),  00721902246234 (PKK001569R),  00613994581174 (PKK001582R),  00613994175212 (PKK001591R),  00613994136527 (PKK001596R),  00721902246234 (PKK001601R),  00721902246234 (PKK001602R),  00613994175120 (PKK001603R),  00613994175120 (PKK001607R),  00613994581174 (PKK001609R),  00721902246241 (PKK001611R),  00613994136534 (PKK001612R),  00613994581235 (PKK001613R),  00613994175083 (PKK001627R),  00643169537828 (PKK001631R),  00613994175083 (PKK001632R),  00613994581174 (PKK001636R),  00613994175106 (PKK001640R),  00613994175212 (PKK001646R),  00613994175106 (PKK001647R),  00613994175120 (PKK001648R),  00721902246241 (PKK001649R),  00613994581013 (PKK001653R),  00613994581075 (PKK001660R),  00721902246234 (PKK001669R),  00613994175106 (PKK001670R),  00613994175083 (PKK001672R),  00721902246234 (PKK001673R),  00613994175120 (PKK001679R),  00721902246234 (PKK001680R),  00613994175397 (PKK001681R),  00613994175106 (PKK001684R),  00613994581594 (PKK001696R),  00613994175120 (PKK001699R),  00613994136534 (PKK001705R),  00613994580863 (PKK001707R),  00643169537828 (PKK001716R),  00613994580894 (PKK001719R),  00613994175106 (PKK001721R),  00613994175397 (PKK001724R),  00613994175212 (PKK001727R),  00613994175175 (PKK001728R),  00721902246241 (PKK001729R),  00613994136527 (PKK001735R),  00613994581204 (PKK001738R),  00613994581235 (PKK001739R),  00613994581075 (PKK001748R),  00613994175120 (PKK001752R),  00613994136527 (PKK001755R),  00721902246289 (PKK001756R),  00613994175106 (PKK001761R),  00613994175106 (PKK001763R),  00613994581228 (PKK001764R),  00721902246241 (PKK001765R),  00613994581174 (PKK001766R),  00613994175120 (PKK001768R),  00613994136497 (PKK001772R),  00613994581075 (PKK001776R),  00613994175106 (PKK001777R),  00613994136527 (PKK001782R),  00613994581051 (PKK001786R),  00613994175106 (PKK001789R),  00613994581181 (PKK001792R),  00721902246234 (PKK001795R),  00613994136497 (PKK001796R),  00613994175090 (PKK001805R),  00613994175106 (PKK001807R),  00613994581075 (PKK001808R),  00613994175212 (PKK001811R),  00613994175212 (PKK001812R),  00613994581174 (PKK001813R),  00613994175106 (PKK001814R),  00613994581204 (PKK001820R),  00721902246234 (PKK001821R),  00613994175120 (PKK001825R),  00613994175175 (PKK001826R),  00721902246234 (PKK001832R),  0… (truncated, 638419 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 4, 2020

CareFusion Alaris Syringe Module, Model 8110

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

ALL 50 STATES
▸Full report

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

Recall #:
84579
Lot/product code:
Software versions 12.1.0, and 9.33 and prior
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)