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Recalls affecting Delaware

Data last updated: September 8, 2026 at 1:13 PM UTC

16,320 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

▸Full report
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

▸Full report
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

▸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

▸Full report
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)

▸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)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

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

Undeclared milk

▸Full report
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

▸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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

ALL 50 STATES
▸Full report

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

Recall #:
99339
Lot/product code:
UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 30, 2026

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

ALL 50 STATES
▸Full report

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

Recall #:
99339
Lot/product code:
UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
Recalling firm:
AVID Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Duo Precision IV Pump, 40002-0403

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

ALL 50 STATES
▸Full report

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

Recall #:
98872
Lot/product code:
UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Solo Precision IV Pump, 40001-0401

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

ALL 50 STATES
▸Full report

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

Recall #:
98872
Lot/product code:
UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

ALL 50 STATES
▸Full report

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

Recall #:
D-0545-2026
Lot/product code:
Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

ALL 50 STATES
▸Full report

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

Recall #:
D-0514-2026
Lot/product code:
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Plum Duo Infusion Pump, 40002-0401

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

ALL 50 STATES
▸Full report

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

Recall #:
98872
Lot/product code:
UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Sterile anchors my lack sterility assurance.

ALL 50 STATES
▸Full report

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

Recall #:
98941
Lot/product code:
GTIN: 08714729905318/Lot # 35107836
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

Reusable electrodes may not meet expected performance levels.

ALL 50 STATES
▸Full report

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

Recall #:
98939
Lot/product code:
All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

ALL 50 STATES
▸Full report

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

Recall #:
D-0516-2026
Lot/product code:
Lot#: PA10734, Exp. Jun 2026.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

ALL 50 STATES
▸Full report

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

Recall #:
D-0515-2026
Lot/product code:
Lot#: PA07434, Exp. May 2026.
Recalling firm:
Ajanta Pharma Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

ALL 50 STATES
▸Full report

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

Recall #:
98891
Lot/product code:
1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009; 16. Product Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010; 17. Product Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325; 19. Product Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051; 21. Product Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260; 23. Product Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028; 24. Product Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;
Recalling firm:
Mozarc Medical US LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)

Reusable electrodes may not meet expected performance levels.

ALL 50 STATES
▸Full report

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

Recall #:
98939
Lot/product code:
All Lots: / UDI: CSK-TC10:00813250010107; CSK-TC10-3M: 00813250011524; CSK-TC15 00813250010114; CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140; CSK-TC5: 00813250010091; CSK-TC5-3M: 00813250011531;
Recalling firm:
Boston Scientific Neuromodulation Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 29, 2026

Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

ALL 50 STATES
▸Full report

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

Recall #:
98891
Lot/product code:
1. Product Number (CFN): 8888221413; UDI-DI: 10884521788541; Lot numbers: 241620022, 252020038; 2. Product Number (CFN): 8888222416; UDI-DI: 10884521788602; Lot numbers: 241690023, 241830147; 3. Product Number (CFN): 8888221416; UDI-DI: 10884521788558; Lot numbers: 251250041, 251740190, 252020039, 252090031, 253350256; 4. Product Number (CFN): 8888222420; UDI-DI: 10884521788619; Lot numbers: 251740186, 252510026, 253280016; 5. Product Number (CFN): 8888221420; UDI-DI: 10884521788565; Lot numbers: 241620407, 251950032; 6. Product Number (CFN): 8888222424; UDI-DI: 10884521788626; Lot number: 243040007; 7. Product Number (CFN): 8888221424; UDI-DI: 10884521788572; Lot numbers: 241200034, 251250039, 252020037; 8. Product Number (CFN): 8888221430; UDI-DI: 10884521788589; Lot number: 251250042; 9. Product Number (CFN): 8888233413; UDI-DI: 10884521788718; Lot number: 250310009; 10. Product Number (CFN): 8888233416; UDI-DI: 10884521788725; Lot numbers: 250350008, 250690152, 250690153, 250870012, 251010012, 251010013, 251320332, 251320333, 251390368, 251390369, 252580023; 11. Product Number (CFN): 8888233420; UDI-DI: 10884521788732; Lot numbers: 250870013, 250970052, 251320330, 251320331; 12. Product Number (CFN): 8888231420; UDI-DI: 10884521788688; Lot numbers: 241690216, 252020046, 252230023, 252580025; 13. Product Number (CFN): 8888233424; UDI-DI: 10884521788749; Lot numbers: 251740197, 252300054; 14. Product Number (CFN): 8888231424; UDI-DI: 10884521788695; Lot numbers: 251460351, 251740196, 252020045, 252230022, 252580024; 15. Product Number (CFN): 8888231430; UDI-DI: 10884521788701; Lot number: 252730009; 16. Product Number (CFN): 8888231413; UDI-DI: 10884521788664; Lot number: 250310010; 17. Product Number (CFN): 8888231416; UDI-DI: 10884521788671; Lot numbers: 252230021, 252510030, 252650294, 253140280; 18. Product Number (CFN): 8888213416; UDI-DI: 10884521788527; Lot number: 252300325; 19. Product Number (CFN): 8888211416; UDI-DI: 10884521788435; Lot numbers: 241060237, 250830187, 250900067, 251250037, 251430012, 252870014; 20. Product Number (CFN): 8888213420; UDI-DI: 10884521788534; Lot number: 252300051; 21. Product Number (CFN): 8888211420; UDI-DI: 10884521788442; Lot numbers: 241480021, 242390056, 250070005, 250310011, 250310012, 250760180, 250900066, 251250035, 251950034; 22. Product Number (CFN): 8888212413; UDI-DI: 10884521788473; Lot number: 242950260; 23. Product Number (CFN): 8888211413; UDI-DI: 10884521788428; Lot number: 252510028; 24. Product Number (CFN): 8888212416; UDI-DI: 10884521788480; Lot numbers: 243160028, 250760159, 251250036, 251320325; 25. Product Number (CFN): 8888212420; UDI-DI: 10884521788497; Lot numbers: 241350005, 250310006, 251740192, 252160037; 26. Product Number (CFN): 8888211424; UDI-DI: 10884521788459; Lot numbers: 250830185, 250830186, 250900298, 250900299, 251740179, 251950033;
Recalling firm:
Mozarc Medical US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 29, 2026

Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

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

Recall #:
D-0544-2026
Lot/product code:
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled April 28, 2026

Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.

Presence of Particulate Matter.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0540-2026
Lot/product code:
Lot #:J4P756, J4S843, Exp 5/31/2027
Recalling firm:
B BRAUN MEDICAL INC
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UnclassifiedRisk not yet known
Medical deviceRecalled April 28, 2026

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

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

Recall #:
98812
Lot/product code:
1. Model Number [UDI]: 722063 [(01)00884838085275(21)77, (01)00884838085275(21)47, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)43, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)97, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)116, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)137, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)78, (01)00884838085275(21)76, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)87, (01)00884838085275(21)85, (01)00884838085275(21)89, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55]; 722229 [(01)00884838116726(21)7, (01)00884838116726(21)3, (01)00884838116726(21)10, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13]. 2. Model Number [UDI]: 722064 [(01)00884838085282(21)513, (01)00884838085282(21)61, (01)00884838085282(21)162, (01)00884838085282(21)161, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)479, (01)00884838085282(21)190, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)502, (01)00884838085282(21)425, (01)00884838085282(21)89, (01)00884838085282(21)303, (01)00884838085282(21)130, (01)00884838085282(21)157, (01)00884838085282(21)60, (01)00884838085282(21)253, (01)00884838085282(21)280, (01)00884838085282(21)373, (01)00884838085282(21)417, (01)00884838085282(21)277, (01)00884838085282(21)102, (01)00884838085282(21)467, (01)00884838085282(21)461, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)510, (01)00884838085282(21)49, (01)00884838085282(21)246, (01)00884838085282(21)282, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)274, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)329, (01)00884838085282(21)276, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)249, (01)00884838085282(21)156, (01)00884838085282(21)380, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)197, (01)00884838085282(21)289, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)448, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)278, (01)00884838085282(21)55, (01)00884838085282(21)39, (01)00884838085282(21)45, (01)00884838085282(21)66, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)183, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)293, (01)00884838085282(21)379, (01)00884838085282(21)292, (01)00884838085282(21)321, (01)00884838085282(21)151, (01)00884838085282(21)237, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)391, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)79, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)252, (01)00884838085282(21)91, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)309, (01)00884838085282(21)400, (01)00884838085282(21)251, (01)00884838085282(21)480, (01)00884838085282(21)387, (01)00884838085282(21)269, (01)00884838085282(21)111, (01)00… (truncated, 152275 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 28, 2026

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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

Recall #:
98801
Lot/product code:
1. Integris CV Cesar-Powerpack-Visub-Nicol; Model: 722030; UDI-DI: N/A; Serial Numbers: 4888270, 59, 0, 33; 2. Integris Allura 15 & 12 (monoplane) (722043); UDI-DI: N/A; Serial Numbers: 365, 18151, 176, 239, 407, 426, 0; 3. INTEGRIS Allura 15-12 (biplane) (722044); UDI-DI: N/A; Serial Numbers: 86322, 30, 66; 4. Integris-Allura 9 (722018); UDI-DI: N/A; Serial Numbers: 26, 85; 5. Integris-Allura 9 (Biplane) (722021); UDI-DI: N/A; Serial numbers: 22, 75, 25, 108; 6. Integris H5000 C / Allura 9C (722016); UDI-DI: N/A; Serial Numbers: 4059001008, 4807240, S01H003553/000001;
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 28, 2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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

Recall #:
98801
Lot/product code:
1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)62, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)93, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54, (01)00884838085275(21)46, (01)00884838085275(21)26, (01)00884838085275(21)71, (01)00884838085275(21)106, (01)00884838085275(21)83, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, 2. Azurion 3 M15; Model: 722064; UDI: (01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161, (01)00884838085282(21)162, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)89, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)213, (01)00884838085282(21)212, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)186, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)230, (01)00884838085282(21)176, (01)00884838085282(21)150, (01)00884838085282(21)149, (01)00884838085282(21)44, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)69, (01)00884838085282(21)39, (01)00884838085282(21)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)70, (01)00884838085282(21)50, (01)00884838085282(21)138, (01)00884838085282(21)151, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)98, (01)00884838085282(21)79, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)91, (01)00884838085282(21)74, (01)00884838085282(21)73, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)133, (01)00884838085282(21)7, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)100, (01)00884838085282(21)51, (01)00884838085282(21)118, (01)00884838085282(21)62, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)272, (01)00884838085282(21)110, (01)00884838085282(21)59, (01)00884838085282(21)167, (01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)41, (01)00884838085282(21)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)86, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)143, (01)00884838085282(21)226, (01)00884838085282(21)43, (01)00884838085282(21)80, (01)00884838085282… (truncated, 52840 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 28, 2026

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

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

Recall #:
98801
Lot/product code:
Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)00884838059030(21)1431, (01)00884838059030(21)1404, (01)00884838059030(21)1140, (01)00884838059030(21)1429, (01)00884838059030(21)1430, (01)00884838059030(21)1403, (01)00884838059030(21)1393, (01)00884838059030(21)1402, (01)00884838059030(21)406, (01)00884838059030(21)71, (01)00884838059030(21)1434, (01)00884838059030(21)1392, (01)00884838059030(21)1379, (01)00884838059030(21)1401, (01)00884838059030(21)1197, (01)00884838059030(21)1435, (01)00884838059030(21)1346, (01)00884838059030(21)232, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1137, (01)00884838059030(21)1446, (01)00884838059030(21)1422, (01)00884838059030(21)1433, (01)00884838059030(21)1131, (01)00884838059030(21)1218; 5. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)1052, (01)00884838054189(21)1051, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)1072, (01)00884838054189(21)796, (01)00884838054189(21)1248, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)969, (01)00884838054189(21)1246, (01)00884838054189(21)877, (01)00884838054189(21)843, (01)00884838054189(21)1231, (01)00884838054189(21)1038, (01)00884838054189(21)1287, (01)00884838054189(21)878, (01)00884838054189(21)558, (01)00884838054189(21)633, (01)00884838054189(21)1050, (01)00884838054189(21)1000, (01)00884838054189(21)909, (01)00884838054189(21)841, (01)00884838054189(21)713, (01)00884838054189(21)731, (01)00884838054189(21)646, (01)00884838054189(21)728, (01)00884838054189(21)765, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)774, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)627, (01)00884838054189(21)604, (01)00884838054189(21)716, (01)00884838054189(21)1182, (01)00884838054189(21)965, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)694, (01)00884838054189(21)838, (01)00884838054189(21)973, (01)00884838054189(21)985, (01)00884838054189(21)855, (01)00884838054189(21)612, (01)00884838054189(21)725, (01)00884838054189(21)805, (01)00884838054189(21)622, (01)00884838054189(21)1293, (01)00884838054189(21)1205, (01)00884838054189(21)617, (01)00884838054189(21)1101, (01)00884838054189(21)738, (01)00884838054189(21)957, (01)00884838054189(21)1340, (01)00884838054189(21)653, (01)00884838054189(21)663, (01)00884838054189(21)688, (01)00884838054189(21)704, (01)00884838054189(21)931, (01)00884838054189(21)967, (01)00884838054189(21)826, (01)00884838054189(21)998, (01)00884838054189(21)807, (01)00884838054189(21)986, (01)00884838054189(21)962, (01)00884838054189(21)961, (01)00884838054189(21)1049, (01)00884838054189(21)707, (01)00884838054189(21)866, (01)00884838054189(21)759, (01)00884838054189(21)1115, (01)00884838054189(21)830, (01)00884838054189(21)638, (01)00884838054189(21)1316, (01)00884838054189(21)748, (01)00884838054189(21)1278, (01)00884838054189(21)1104, (01)00884838054189(21)… (truncated, 82220 characters total — see the official FDA record for the full value)
Recalling firm:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

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

Recall #:
98842
Lot/product code:
1. Catalog Numbers: 400868. UDI Numbers: (01)10885403469510(17)261001(10)B01V206D, (01)10885403469510(17)261001(10)B01V220D, (01)10885403469510(17)270101(10)B02V266D. Lot Number (Expiration Date): B01V206D (2026-10-01), B01V220D (2026-10-01), B02V266D (2027-01-01). 2. Catalog Number: 405652. UDI Numbers: (01)00382904056520(17)270130(10)B01V353D, (01)00382904056520(17)270101(10)B02V267D. Lot Numbers (Expiration Date): B01V353D (2027-01-30), B02V267D (2027-01-01).
Recalling firm:
Becton Dickinson & Company
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
UDI-DI 10198459366390 Lot 25KBL873
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
DYNJ904305J UDI-DI 10198459268151 lot 25KBT972 DYNJ69533C UDI-DI 10198459524097 lot 26BBC483
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
Recalling firm:
Medline Industries, LP
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UnclassifiedRisk not yet known
Medical deviceRecalled April 27, 2026

Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

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

Recall #:
98951
Lot/product code:
EBSI1688 UDI-DI 10653160370130 Lot 2025102890 EBSI1328A UDI-DI 10653160382980 Lot 2025103090
Recalling firm:
Medline Industries, LP
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