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Recalls affecting Alabama

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

16,908 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

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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.

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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

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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.

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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

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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

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

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

Recall #:
98285
Lot/product code:
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

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

Recall #:
98284
Lot/product code:
UDI/DI 10195327379308, Lot Number 25EBO576
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission

There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).

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

Recall #:
98269
Lot/product code:
OMNI Legend 16: UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071; OMNI Legend 16: UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100; OMNI Legend 16: UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115; OMNI Legend 16: UDI (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/Serial Number OH3D35001; OMNI Legend 16: UDI (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/Serial Number OH3E35003; Omni Legend 21: UDI (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/Serial Number OM4E44014; Omni Legend 21: UDI (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/Serial Number OM4E44012; Omni Legend 21: UDI (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/Serial Number OH4E43004; Omni Legend 21: UDI (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/Serial Number OH4E43001; Omni Legend 21: UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084; OMNI Legend 32: UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031; OMNI Legend 32: UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097; OMNI Legend 32: UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM; Omni Legend PET Gantry 16cm - MEA: UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM; Omni Legend PET Gantry 16cm Haifa LM: UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008; Omni Legend PET Gantry 16cm Mobile: UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Seri… (truncated, 44945 characters total — see the official FDA record for the full value)
Recalling firm:
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

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

Recall #:
98235
Lot/product code:
Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004" ; Lot No. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610005" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611001" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611002" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611003" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611004" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611005" ; Lot No. 66722611 ; Serial No. 50066722611005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611006" ; Lot No. 66722611 ; Serial No. 50066722611006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611007" ; Lot No. 66722611 ; Serial No. 50066722611007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611008" ; Lot No. 66722611 ; Serial No. 50066722611008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611009" ; Lot No. 66722611 ; Serial No. 50066722611009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611010" ; Lot No. 66722611 ; Serial No. 50066722611010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892001" ; Lot No. 66742892 ; Serial No. 50066742892001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892002" ; Lot No. 66742892 ; Serial No. 50066742892002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892003" ; Lot No. 66742892 ; Serial No. 50066742892003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892004" ; Lot No. 66742892 ; Serial No. 50066742892004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892005" ; Lot No. 66742892 ; Serial No. 50066742892005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892006" ; Lot No. 66742892 ; Serial No. 50066742892006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892007" ; Lot No. 66742892 ; Serial No. 50066742892007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892008" ; Lot No. 66742892 ; Serial No. 50066742892008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892009" ; Lot No. 66742892 ; Serial No. 50066742892009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892010" ; Lot No. 66742892 ; Serial No. 50066742892010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892016" ; Lot No. 66742892 ; Serial No. 50066742892016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893001" ; Lot No. 66742893 ; Serial No. 50066742893001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893002" ; Lot No. 66742893 ; Serial No. 50066742893002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893003" ; Lot No. 66742893 ; Serial No. 50066742893003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893004" ; Lot No. 66742893 ; Serial No. 50066742893004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893005" ; Lot No. 66742893 ; Serial No. 50066742893005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893006" ; Lot No. … (truncated, 28020 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

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

Recall #:
98284
Lot/product code:
UDI/DI 10653160990666, Lot Number 25EBC648
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
1) Kit SKU DT22710, Lot Numbers: 25EBC812; 2) Kit SKU DYNDA1857A, Lot Numbers: 25FBH991; 3) Kit SKU DYNDC1978A, Lot Numbers: 25EBC577; 4) Kit SKU DYNDC2367, Lot Numbers: 25EBS434; 5) Kit SKU DYNDC2407B, Lot Numbers: 25FMG170; 6) Kit SKU DYNDC3222A, Lot Numbers: 25EBK184; 7) Kit SKU DYNJ59067A, Lot Numbers: 25EBM461, 25EBD386; 8) Kit SKU PHS950205004B, Lot Numbers: 25FMD059.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

ALL 50 STATES
▸Full report

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

Recall #:
98284
Lot/product code:
1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881; 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827; 3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730; 4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629; 5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086; 6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081; 7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351; 8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085; 9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

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

Recall #:
98284
Lot/product code:
UDI/DI 10198459230363, Lot Numbers: 25EBU508, 25EBE330.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit SKU DYNDC3107; 8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C; 9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250; 10) UMBILICAL VESSEL TRAY, Kit SKU UVT835; 11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

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

Recall #:
98284
Lot/product code:
1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888; 2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566; 3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964; 4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178; 5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624; 6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706; 7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742; 8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778; 9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757; 10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300; 11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled December 23, 2025

Bread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags

Not listed on the label Milk Allergen

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

Recall #:
H-0500-2026
Lot/product code:
Lot #072225-217 Lot #072225-218 Lot #080325-200 Lot #080325-201 Lot #081625-203 Lot #081625-204 Lot #092225-222 Lot #092225-223 Lot #092225-224 Lot #092225-225 Lot #092225-226 Lot #092225-227 Lot #092225-228 Lot #101725-208 Lot #101725-209
Recalling firm:
B.C. Williams Bakery Service, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2025

CellMek SPS Sample Preparation System, REF: C44603, with software

Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.

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

Recall #:
98207
Lot/product code:
UDI-DI: 15099590750312. Software Version 2.3.90.0
Recalling firm:
Beckman Coulter, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 23, 2025

Focalyx Fusion

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

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

Recall #:
98137
Lot/product code:
UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324
Recalling firm:
Focalyx Technologies, LLC.
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled December 23, 2025

Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags

Not listed on the label Milk Allergen

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

Recall #:
H-0501-2026
Lot/product code:
072925-220 and 071825-36
Recalling firm:
B.C. Williams Bakery Service, Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenMilkUndeclaredRecalled December 23, 2025

Spice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags

Not listed on the label Milk Allergen

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

Recall #:
H-0499-2026
Lot/product code:
Batch 221
Recalling firm:
B.C. Williams Bakery Service, Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled December 22, 2025

Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39

Failed PH Specifications

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0291-2026
Lot/product code:
Batch XHBG; Exp. 08/31/2027
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 22, 2025

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

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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-0296-2026
Lot/product code:
Lot #: G171359, expiry: 05/31/2027
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit

BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.

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

Recall #:
98245
Lot/product code:
Lot Code: Model No. 2519CP; UDI-DI 00661392048157; Lot# 5G3119; Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731
Recalling firm:
LSL Healthcare Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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▸Full report

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

Recall #:
98277
Lot/product code:
401211RH UDI-DI 10197344043736 Lot EP250317; 401222RH UDI-DI 10197344043712 Lot EP250317; 401223RH UDI-DI 10197344043705 Lot EP250317; 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317; 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317; 401260RH UDI-DI 10197344043668 Lot EP250317; 401261RH UDI-DI 10197344043651 Lot EP250317; 401306RH UDI-DI 10197344043620¿ Lot EP250317; 401309RH UDI-DI 10197344043613 Lot EP250317; 401312RH UDI-DI 10197344043583¿ Lot EP250307; 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317; 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317; 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317; 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317; 401442RH UDI-DI 10197344044245 Lot EP250307; 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317; 401448RH UDI-DI 10197344044283 Lot EP250307; 401449RH UDI-DI 10197344044290 Lot EP250307; 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317; 401451RH UDI-DI 10197344044313 EP250307 EP250317; 401474RH UDI-DI 10197344044351 Lot EP250307; 401860RH UDI-DI 10197344044382 Lots EP250307 EP250317; 401877RH UDI-DI 10197344044436 Lots EP250307 EP250317; 401878RH UDI-DI 10197344044443 Lot EP250307; 401890RH UDI-DI 10197344044450 Lots EP250307 EP250317; 401891RH UDI-DI 10197344044467 Lot EP250307; 401994RH UDI-DI 10197344044542 Lot EP250317; 402012RH UDI-DI 10197344043835 Lots EP250307 EP250317; 402004RH UDI-DI 10197344044566 Lots EP250307 EP250317; 402010RH UDI-DI 10197344044597 Lots EP250307 EP250317; 402008RH UDI-DI 10197344044573 Lot EP250317; 402009RH UDI-DI 10197344044580 Lots EP250307 EP250317 ***Updated 5/18/26*** LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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

Recall #:
98277
Lot/product code:
401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630; 401940RH UDI-DI 10888277407480 Lot EP250618; 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630; 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618; 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630; 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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▸Full report

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

Recall #:
98277
Lot/product code:
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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▸Full report

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

Recall #:
98277
Lot/product code:
BD710DF282CRH UDI-DI 10197344044023 Lots EP250429 EP250808; BD710DF282RRH UDI-DI 10197344044030 Lots EP250429 EP250808; BD710FJ282RRH UDI-DI 10197344044054 Lots EP250429 EP250808; BD710FJ282CRH UDI-DI (case) 40197344044048 (ea) 10197344044047 Lots EP250429 EP250808
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Patient Information Center iX; Software Version Number: 4.5.0

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

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

Recall #:
98217
Lot/product code:
Model Numbers: (1) 866389, (2) 866390; UDI-DI: (1) 00884838127074, (2) N/A; Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E, 0F2U-1BLC-H, 291E-7HJU-A, 1M6W-1UP5-1, 4620-0XNW-5, 4W5R-3FHA-L, 6B73-3ZKP-K, 3E79-49M4-3, 4F6Y-70HU-P, 0128-2WG5-0, 0830-3RLW-W, 097K-7LPC-5, 0D2V-1BLC-8, 120T-17M9-A, 173C-20JM-J, 190B-64MU-U, 1K2J-15LB-P, 1L3T-7KGB-E, 2K06-4ZPR-X, 3916-5DJ6-Z, 3V7H-06MT-E, 412A-2WG5-Y, 4271-2NL7-M, 4Z3L-5PP3-0, 5D0E-3EH3-3, 5E0B-3EH3-D, 5E25-14LG-9, 657X-31N5-L, 6G5U-3FHA-R, 781T-7TJA-B, 7N3U-51MJ-B, 7P31-7NPM-P, 283X-7ZPB-A, 7H77-09GU-Z, 4C59-26K6-P, 4N0L-0FKE-2, 5Y0A-02P6-L, 494H-1CJJ-3, 326G-7PGV-A, 292G-3YNZ-9, 0V2A-6DHP-0, 6354-58M8-C, 4W5B-6JK9-A, 5M7K-0VKT-T, 3401-1FHE-M, 6R30-5BNT-N, 6N2E-7YK1-1, 6R0H-6AMX-T, 107C-62PF-Y, 2X1T-7TJA-H, 1M6G-7PGV-K, 1C4Z-6KKD-H, 0B3Z-2RHR-L, 7H39-3JGK-U, 0M0V-6FKB-5, 793D-41PZ-X, 233G-46MR-V, 782Z-3RLW-D, 5N2B-5YJP-G, 0L5F-0ZNF-J, 4G4N-2LKY-K, 2M48-4XM7-Y, 133W-3UN7-B, 295N-0YG8-Y, 5D7W-00G0-1, 5R78-6CPV-0, 3C79-49M4-9, 3T24-5CKL-A, 6H74-27LY-T, 186W-1UP5-8, 0021-1DNN-P, 0247-7ELE-R, 0D5Y-32PN-A, 0J7W-31N5-2, 0R2W-1VNP-P, 0Y5Z-7FHX-N, 121L-1KG1-M, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 1C19-1MHK-F, 1G0F-69LP-G, 1J5U-5HMV-N, 1P4F-34MB-W, 1P5C-6JK9-D, 212R-6HHJ-P, 221V-7TJA-4, 227N-7JG6-J, 232W-7DL9-G, 2A5X-2PJT-0, 2A75-27LY-3, 2F5J-0JLM-7, 2J19-1MHK-W, 2L16-59N8-M, 2M73-5WKF-U, 2N3V-6YM2-X, 2P6J-7PGV-E, 2Y5M-5AGH-E, 326W-21KC-B, 332M-47P7-Y, 3A29-0CKW-3, 3C0U-7AHH-6, 3C2U-05HF-W, 3E05-4ZPR-U, 3G6H-39G4-Y, 3H1T-22HW-5, 3H5R-5HMV-M, 3H79-09GU-5, 3J2K-2TP9-1, 3W1Y-3CH6-J, 4L7Y-00G0-F, 4M77-1HM0-G, 4N3D-20JM-K, 4R0G-60JV-1, 4V2Z-7NPM-M, 4W08-0UH7-U, 4X6C-1PJ5-J, 4Y08-0UH7-L, 500W-6WNX-A, 594D-0EG2-9, 5U0A-3WPK-C, 5W1G-50P2-N, 5Z6J-3HL1-B, 617W-31N5-F, 637V-7BG9-W, 673T-67ME-B, 686N-3NNV-6, 6D3P-4WMG-A, 6K70-3XNY-W, 6P42-35J4-V, 6U1T-75JN-Y, 771A-2JPY-0, 7F5L-73HZ-3, 7G3A-13JG-L, 7K0P-4AH2-6, 7Z2R-05HF-X, 1J1P-6PKN-T, 4R7H-7LPC-J, 282N-0WPA-X, 5G35-04K8-E, 366L-2XHV-A, 5L7D-2UGW-T, 4N0L-0FKE-2;
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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▸Full report

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

Recall #:
98277
Lot/product code:
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

ALL 50 STATES
▸Full report

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

Recall #:
98277
Lot/product code:
81105RH UDI-DI 10197344133253 Lot EP250618; 81172RH UDI-DI 10197344133284 Lot EP250618; 81202RH UDI-DI 10197344133307 Lot EP250618; 81483RH UDI-DI 10197344133444 Lot EP250618; 81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618; 81104RH UDI-DI 10197344133246 Lot EP250618; 81174RH UDI-DI 10197344133291 Lot EP250618; 81531RH UDI-DI 10197344133512 Lot EP250618; 81532RH UDI-DI 10197344133529 Lot EP250618; 81107RH UDI-DI 10197344133260 Lot EP250618; 81402RH UDI-DI 10197344133352 Lot EP250618; 81404RH UDI-DI 10197344133376 Lot EP250618; 81405RH UDI-DI 10197344133383 Lot EP250618; 81474RH UDI-DI 10197344133437 Lot EP250618; 81473RH UDI-DI 10197344133420 Lot EP250618
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2025

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

ALL 50 STATES
▸Full report

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

Recall #:
98277
Lot/product code:
10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905; 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)