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Recalls affecting Delaware

Data last updated: September 10, 2026 at 1:16 PM UTC

16,320 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

▸Full report
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)

▸Full report
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

▸Full report
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

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

ALL 50 STATES
▸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 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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▸Full report

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

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

ALL 50 STATES
▸Full report

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

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection

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▸Full report

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

Recall #:
87802
Lot/product code:
Lot Number: 203373129 Exp. Date: June 30, 2022
Recalling firm:
Vygon U.S.A.
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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▸Full report

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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▸Full report

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.

ALL 50 STATES
▸Full report

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

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

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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 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

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

ALL 50 STATES
▸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

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 23, 2021

The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.

DEOHUT
▸Full report

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

Recall #:
87849
Lot/product code:
Lot 280819
Recalling firm:
CooperSurgical, Inc.
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.

ALL 50 STATES
▸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 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.

ALL 50 STATES
▸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 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.

ALL 50 STATES
▸Full report

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 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

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

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.

ALL 50 STATES
▸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
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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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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
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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.

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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
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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
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UnclassifiedRisk not yet known
Medical deviceRecalled May 1, 2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A  728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941 N/A 728243 75047 N/A 728243 7467 N/A 728243 7831 N/A 728243 7831 N/A 728243 7560 N/A 728243 75067 N/A 728243 7689 N/A 728243 7442 N/A 728243 75111 N/A 728243 7927 N/A 728243 7558 N/A 728243 7769 N/A 728243 7284 N/A 728243 75066 N/A 728243 7905 N/A 728243 7800 N/A 728243 7724 N/A 728243 7946 N/A 728243 7385 N/A 728243 7192 N/A 728243 7211 N/A 728243 7891 N/A 728243 75041 N/A 728243 7269 N/A 728243 7064 N/A 728243 7116 N/A 728243 7214 N/A 728243 7795 N/A 728243 7701 N/A 728243 7810 N/A 728243 7743 N/A 728243 75064 N/A 728243 75120 N/A 728243 750005 N/A 728243 750013 N/A  728244 760014 (01)00884838059450(21)760014 728244 760013 (01)00884838059450(21)760013 728244 76230 N/A 728244 76259 (01)00884838059450(21)76259 728244 76238 (01)00884838059450(21)76238 728244 76147 (01)00884838059450(21)76147 728244 76178 (01)00884838059450(21)76178 728244 7764 N/A 728244 760045 (01)00884838059450(21)760045 728244 760023 (01)00884838059450(21)760023 728244 75123 N/A 728244 760047 (01)00884838059450(21)760047 728244 76109 (01)00884838059450(21)76109 728244 760056 (01)00884838059450(21)760056 728244 7653 N/A 728244 76249 (01)00884838059450(21)76249 728244 76228 (01)00884838059450(21)76228 728244 76299 (01)00884838059450(21)76299 728244 7926 N/A 728244 7533 N/A 728244 7917 N/A 728244 76095 (01)00884838059450(21)76095 728244 7874 N/A 728244 7452 N/A 728244 76113 (01)00884838059450(21)76113 728244 76140 (01)00884838059450(21)76140 728244 76078 (01)00884838059450(21)76078 728244 7781 N/A 728244 76079 (01)00884838059450(21)76079 728244 760015 (01)00884838059450(21)760015 728244 760029 N/A 728244 760011 (01)00884838059450(21)760011 728244 7694 N/A 728244 76248 N/A 728244 7747 N/A 728244 7773 (01)00884838059450(21)7773 728244 7826 N/A 728244 76290 (01)00884838059450(21)76290 728244 7915 N/A 728244 7721 N/A 728244 76268 (01)00884838059450(21)76268 728244 76177 (01)00884838059450(21)76177 728244 760003 (01)00884838059450(21)760003 728244 760004 (01)00884838059450(21)760004 728244 76214 (01)00884838059450(21)76214 728244 76250 (01)00884838059450(21)76250
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 Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201

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

Recall #:
87974
Lot/product code:
Model/ Serial Number/UDI: 728120 2516 N/A 728120 3179 N/A 728120 3316 N/A 728201 9326 N/A 728120 3304 N/A 728120 3271 N/A 728120 2537 N/A 728120 3324 N/A 728120 H3321 N/A 728120 3058 N/A 728125 2529 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 Bracket Assembly for use with CT and MX16 Models: 728131

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
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)