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Recalls affecting Guam

Data last updated: September 11, 2026 at 1:08 PM UTC

15,987 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)
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)
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)
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 April 15, 2021

Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210

Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection

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

Recall #:
87709
Lot/product code:
All unexpired lots: C003699 C003715 C003735 C003750 C003775 C003804 C003813 C003842 C003853 C003887 C003905 C003936 C003950 C003960 C003966 C003986 C003997 C004028 C004041 C004078 C004091 C004107 C004117 C004128 C004136 C004160 C004186 C004206 C004221  GTIN 08714729848097
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 15, 2021

Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.

Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).

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

Recall #:
87766
Lot/product code:
Software version 9.3.1
Recalling firm:
Haag-Streit USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 15, 2021

UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.

Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection

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▸Full report

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

Recall #:
87709
Lot/product code:
All unexpired lots: C003726 C003737 C003739 C003752 C003767 C003778 C003782 C003791 C003814 C003818 C003831 C003845 C003846 C003874 C003875 C003898 C003899 C003921 C003942 C003954 C003970 C003988 C003989 C003999 C004000 C004011 C004012 C004031 C004032 C004033 C004048 C004049 C004084 C004085 C004086 C004097 C004098 C004099 C004120 C004132 C004143 C004150 C004159 C004175 C004176 C004196 C004205 C004213 C004218 C004223  GTIN: 08714729848103
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2021

Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

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

Recall #:
87891
Lot/product code:
Software version 2.0 and 2.1.
Recalling firm:
CHANGE HEALTHCARE CANADA COMPANY
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 19, 2021

Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

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

Recall #:
87864
Lot/product code:
Lot Number: 105013A
Recalling firm:
EHOB, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 20, 2021

Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock" Suspension System. This system allows you to interchange suspension methods without remaking a socket Model, 3 part numbers - 700-AIS100, Alpha Interlock Suspension System with Alpha Lanyard - 700-AIS101, Alpha Interlock Suspension System with Alpha Lanyard w/Titanium Pyramid - 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY

The firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.

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

Recall #:
87825
Lot/product code:
Lot: 'xx' stamped on the outside of the Lanyard body manufactured form 04/01/2020 - 04/08/2021
Recalling firm:
WillowWood Global Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

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▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520;  KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520;  KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420;  KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220;  KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420;  KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220;  KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820;  KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820;  KIR 21/20: LOT: 3617, 1020;  KIR17/15: LOT: 2417, 5117, 0918;  KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493

Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems

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

Recall #:
87770
Lot/product code:
All Lots
Recalling firm:
Siemens Healthcare Diagnostics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

ALL 50 STATES
▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  BIM 18/10: LOT: 4918;  BIM 18/15: LOT: 4017, 4918, 4719;  BIM 18/20: LOT: 4017, 4918;  BIM 16/10: LOT: 4918, 1119, 1219;  BIM 16/15: LOT: 4918, 1119;  BIM 16/20: LOT: 4918, 1119;  BIM 14/10: LOT: 4918, 3019;  BIM 14/15: LOT: 4918;  BIM 14/20: LOT: 4918
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

ALL 50 STATES
▸Full report

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

Recall #:
88213
Lot/product code:
Affected Lot Numbers:  KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820;  KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820;  KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520;  KIM 22/15: LOT: 1417, 2118,4319;  KIM 20/10: LOT: 4318;  KIM 20/15: LOT: 4318;  KIM 18/10: LOT: 0717, 4318;  KIM 18/10T: LOT: 0217;  KIM 18/15: LOT: 0717, 4318, 0920;  KIM 18/15T: LOT: 4318;  KIM 18/20: LOT: 4318;  KIM 13/04T: LOT: 0817, 4318;  KIM 13/09T: LOT: 0817, 4318;  KIM 13/14T: LOT: 0817, 4318;  KIM 15/04T: LOT: 2818;  KIM 15/09T: LOT: 2818;  KIM 15/14T: LOT: 2818;  KIM 16/04T: LOT: 2818, 4820;  KIM 16/09T: LOT: 2818, 4820, 5020;  KIM 16/14T: LOT: 2818, 4820;  KIM 14/20T: LOT: 2419;
Recalling firm:
INNOVATIVE TOMOGRAPHY PRODUCT GMBH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 21, 2021

RAPTAR Laser Range Finders

RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.

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

Recall #:
88735
Lot/product code:
RAPTAR G02 (Wilcox Part #57200G02)
Recalling firm:
Potomac River Group, Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

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

Recall #:
87737
Lot/product code:
All Lots distributed within the U.S.
Recalling firm:
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

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

Recall #:
87854
Lot/product code:
UDI: 04015630918904
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 26, 2021

Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

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▸Full report

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

Recall #:
87737
Lot/product code:
All Lots distributed within the U.S.
Recalling firm:
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2021

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

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

Recall #:
88000
Lot/product code:
Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
Recalling firm:
Circulatory Technology Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984  Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

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▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237  Lot Number: 20J0699FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

ALL 50 STATES
▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 10884521077409 GTIN Secondary Package: 20884521077406  Lot Numbers: 20C1164FAX 20C1165FAX 20C1166FAX 20C1235FAX 20C1236FAX 20D1187FAX 20D1188FAX 20D1189FAX 20D1190FAX 20D1191FAX 20D1429FAX 20D1430FAX 20D1432FAX 20D1433FAX 20D1523FAX 20D1524FAX 20D1525FAX 20D1526FAX 20D1527FAX 20D1528FAX 20E0158FAX 20E0159FAX 20E0160FAX 20E0161FAX 20E0162FAX 20E0163FAX 20E0164FAX 20E0165FAX 20E0390FAX 20E0391FAX 20E0392FAX 20E0393FAX 20E0871FAX 20E0873FAX 20E0874FAX 20E0875FAX 20E0935FAX 20E0936FAX 20E0997FAX 20E0998FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2021

HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

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▸Full report

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

Recall #:
87925
Lot/product code:
GTIN Primary Package: 10884521779372 GTIN Secondary Package: 20884521779379  Lot Numbers: 19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2021

ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.

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

Recall #:
88040
Lot/product code:
Lot Numbers/ Exp. Date: 80516 31/07/2021; 80635 30/09/2021; 90092 31/12/2021; 90599 31/12/2021; 00118 31/12/2021; 00360 31/12/2021; 00610 31/12/2021; 00702 31/12/2021.  UDI: 01)08058056681775( 17)210731( 10)80516(240) 1667001 {01)08058056681775( 17)210930(10)80635{240) 1667001 {01)08058056681775( 17)211231(10)90092(240) 1667001 {01)08058056681775( 17)211231(10)90599{240) 1667001 {01)08058056681775( 17)211231( 10)00118(240) 1667001 {01)08058056681775( 17)211231(10)00360(240) 1667001 {01)08058056681775( 17)211231( 10)00610(240) 1667001 {01)08058056681775( 17)211231(10)00702{240) 1667001
Recalling firm:
Sentinel CH SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

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▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT   728321 52051 N/A 728321 52113 (01)00884838059498(21)52113 728321 52105 (01)00884838059498(21)52105 728321 52106 (01)00884838059498(21)52106 728321 333121 N/A 728321 52018 N/A 728321 310113 N/A 728321 310114 N/A 728321 310128 N/A 728321 310162 N/A 728321 333024 N/A 728321 52159 (01)00884838059498(21)52159 728321 52129 N/A 728321 333078 N/A 728321 52079 N/A 728321 52052 N/A 728321 333057 N/A 728321 333059 N/A 728321 941164 N/A 728321 333132 N/A 728321 333146 N/A 728321 30025 N/A 728321 333043 N/A 728321 333150 N/A 728321 333071 N/A 728321 52110 (01)00884838059498(21)52110 728321 333159 (01)00884838059498(21)333159 728321 52020 N/A 728321 310063 N/A 728321 310141 N/A 728321 310133 N/A 728321 52153 (01)00884838059498(21)52153 728321 333151 N/A 728321 333060 N/A 728321 310377 (01)00884838059498(21)310377 728321 333094 N/A 728321 310059 N/A 728321 333135 N/A 728321 333074 N/A 728321 52046 N/A 728321 52046 N/A 728321 52036 N/A 728321 52029 N/A 728321 52037 N/A 728321 52034 N/A 728321 52035 N/A 728321 310385 (01)00884838059498(21)310385 728321 52108 (01)00884838059498(21)52108 728321 333196 (01)00884838059498(21)333196 728321 310119 N/A 728321 52086 (01)00884838059498(21)52086 728321 310036 N/A 728321 333195 (01)00884838059498(21)333195 728321 310157 N/A 728321 333149 N/A 728321 342002 (01)00884838059498(21)342002 728321 333062 N/A 728321 52165 (01)00884838059498(21)52165 728321 52089 (01)00884838059498(21)52089 728321 333006 N/A 728321 310023 N/A 728321 310087 N/A 728321 333114 N/A 728321 333013 N/A 728321 333053 N/A 728321 310289 N/A 728321 310344 (01)00884838059498(21)310344 728321 310308 N/A 728321 310350 (01)00884838059498(21)310350 728321 310262 N/A 728321 310401 (01)00884838059498(21)310401 728321 310346 (01)00884838059498(21)310346 728321 310250 N/A 728321 52144 (01)00884838059498(21)52144 728321 333009 (01)00884838059498(21)333009 728321 310316 N/A 728321 310009 N/A 728321 310297 N/A 728321 310287 N/A 728321 310393 (01)00884838059498(21)310393 728321 310271 N/A 728321 310172 N/A 728321 310064 N/A 728321 310168 N/A 728321 52125 (01)00884838059498(21)52125 728321 310294 N/A 728321 52123 (01)00884838059498(21)52123 728321 68178 (01)00884838059498(21)68178 728321 310103 N/A 728321 310273 N/A 728321 310160 N/A 728321 310272 N/A 728321 310078 N/A 728321 310386 (01)00884838059498(21)310386 728321 310329 N/A 728321 310212 N/A 728321 40037 (01)00884838059498(21)40037 728321 333076 N/A 728321 333175 (01)00884838059498(21)333175 728321 52160 (01)00884838059498(21)52160 728321 52085 (01)00884838059498(21)52085 728321 52097 (01)00884838059498(21)52097 728321 310055 N/A 728321 333037 N/A 728321 52155 (01)00884838059498(21)52155 728321 310372 (01)00884838059498(21)310372 728321 68180 (01)00884838059498(21)68180 728321 333180 (01)00884838059498(21)333180 728321 310069 N/A 728321 52157 (01)00884838059498(21)52157 728321 52096 (01)00884838059498(21)52096 728321 310291 N/A 728321 310299 N/A 728321 310016 N/A 728321 310362 (01)00884838059498(21)310362 728321 336069 N/A 728321 310394 (01)00884838059498(21)310394 728321 333045 N/A 728321 333117 N/A 728321 52107 (01)00884838059498(21)52107 728321 310292 N/A 728321 333167 (01)00884838059498(21)333167 728321 333179 (01)00884838059498(21)333179 728321 333048 N/A 728321 310276 N/A 728321 52115 N/A 728321 52115 N/A 728321 333063 N/A 728321 310379 (01)00884838059498(21)310379 728321 310227 N/A 728321 52064 N/A 728321 333049 N/A 728321 310284 N/A 728321 333069 N/A 728321 310112 N/A 728321 310024 N/A 728321 310051 (01)00884838059498(21)310051 728321 310131 N/A 728321 310038 N/A 728321 68134 (01)00884838059498(21)68134 728321 333214 (01)00884838059498(21)333214 728321 333166 (01)00884838059498(21)333166 728321 310388 (01)00884838059498(21)310388 728321 52024 N/A 728321 333008 N/A 728321 52015 N/A 728321 310159 N/A 728321 52007 N/A 728321 52069 N/A 728321 333050 N/A 728321 333174 (01)00884838059498(21)333174 728321 333110 N/A 728321 333103 N/A 728321 310116 N/A 728321 310204 N/A 728321 333112 N/A 728321 333142 N/A 728321 333199 (01)00884838059498(21)333199 728321 310370 (01)00884838059498(21)310370 728321 333001 N/A 728321 333181 N/A 728321 310224 N/A 728321 310226 N/A 728321 310207 N/A 728321 52019 N/A 728321 310042 N/A 728321 52014 N/A 728321 310357 (01)00884838059498(21)310357 728321 333262 (01)00884838059498(21)333262 728321 52053 N/A 728321 40009 (01)00884838059498(21)40009 728321 52093 (01)00884838059498(21)52093 728321 52099 (01)00884838059498(21)52099 728321 68125 (01)00884838059498(21)68125 728321 52167 (01)00884838059498(21)52167 728321 310121 (01)00884838059498(21)310121 728321 52186 (01)00884838059498(21)52186 728321 52195 (01)00884838059498(21)52195 728321 68161 (01)00884838059498(21)68161 728321 333131 N/A 728321 310302 N/A 728321 310252 N/A 728321 310040 N/A 728321 333242 (01)00884838059498(21)333242  728323 336165 N/A 728323 320429 (01)00884838059504(21)320429 7… (truncated, 15516 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 10016 (01)00884838101111(21)10016 10018 (01)00884838101111(21)10018
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 728332 860005 N/A 728332 395001 N/A 728332 860043 (01)00884838059542(21)860043 728332 860131 (01)00884838059542(21)860131 728332 860050 (01)00884838059542(21)860050 728332 860122 (01)00884838059542(21)860122 728332 60038 (01)00884838059542(21)60038 728332 860177 N/A 728332 860185 (01)00884838059542(21)860185 728332 860172 (01)00884838059542(21)860172 728332 60051 (01)00884838059542(21)60051 728332 60009 N/A 728332 860098 (01)00884838059542(21)860098 728332 60054 (01)00884838059542(21)60054 728332 860199 (01)00884838059542(21)860199 728332 860123 (01)00884838059542(21)860123 728332 860059 (01)00884838059542(21)860059 728332 860199 N/A 728332 860015 N/A 728332 860014 N/A 728332 860096 (01)00884838059542(21)860096 728332 860029 N/A 728332 860073 (01)00884838059542(21)860073 728332 860058 (01)00884838059542(21)860058 728332 860082 (01)00884838059542(21)860082 728332 860069 (01)00884838059542(21)860069 728332 860216 (01)00884838059542(21)860216 728332 860193 (01)00884838059542(21)860193 728332 860118 (01)00884838059542(21)860118 728332 860024 N/A 728332 860204 (01)00884838059542(21)860204 728332 60066 N/A 728332 860154 N/A 728332 860175 (01)00884838059542(21)860175 728332 860186 (01)00884838059542(21)860186 728332 860038 N/A 728332 860078 (01)00884838059542(21)860078 728332 60042 (01)00884838059542(21)60042 728332 860110 (01)00884838059542(21)860110 728332 860027 (01)00884838059542(21)860027 728332 860071 (01)00884838059542(21)860071 728332 860139 (01)00884838059542(21)860139 728332 60014 (01)00884838059542(21)60014 728332 N/A 728332 60040 (01)00884838059542(21)60040 728332 860153 (01)00884838059542(21)860153 728332 860103 (01)00884838059542(21)860103 728332 860075 (01)00884838059542(21)860075 728332 860181 (01)00884838059542(21)860181 728332 860012 N/A 728332 860046 (01)00884838059542(21)860046 728332 860152 (01)00884838059542(21)860152 728332 860054 (01)00884838059542(21)860054 728332 860140 (01)00884838059542(21)860140 728332 860020 N/A 728332 860130 (01)00884838059542(21)860130 728332 860147 (01)00884838059542(21)860147 728332 860061 (01)00884838059542(21)860061 728332 860079 (01)00884838059542(21)860079 728332 860218 (01)00884838059542(21)860218 728332 860149 (01)00884838059542(21)860149 728332 860064 (01)00884838059542(21)860064 728332 860121 (01)00884838059542(21)860121 728332 860109 (01)00884838059542(21)860109 728332 60032 (01)00884838059542(21)60032 728332 860200 (01)00884838059542(21)860200 728332 860041 (01)00884838059542(21)860041 728332 860160 N/A 728332 860090 (01)00884838059542(21)860090 728332 860035 (01)00884838059542(21)860035 728332 860057 (01)00884838059542(21)860057 728332 860017 N/A 728332 860203 (01)00884838059542(21)860203 728332 860008 N/A 728332 860128 (01)00884838059542(21)860128 728332 860129 (01)00884838059542(21)860129 728332 860158 N/A 728332 860209 (01)00884838059542(21)860209 728332 860211 (01)00884838059542(21)860211 728332 60029 (01)00884838059542(21)60029 728332 860183 (01)00884838059542(21)860183 728332 860013 N/A 728332 860091 (01)00884838059542(21)860091
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 882476 9006 N/A
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

ALL 50 STATES
▸Full report

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A System Code System Serial Number Unique Device Identifier (UDI#) 882442 2155 (01)00884838059443(21)2155 882442 2154 (01)00884838059443(21)2154 882442 2166 (01)00884838059443(21)2166 882442 2171 (01)00884838059443(21)2171 882442 2153 (01)00884838059443(21)2153
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)