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Recalls affecting Oregon

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

16,620 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

▸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/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2025

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

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.

ALL 50 STATES
▸Full report

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

Recall #:
98285
Lot/product code:
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

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:
UDI/DI 10193489918007, Lot Number 25EBD612
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: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

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:
UDI/DI 10195327379292, Lot Number 25EBJ785
Recalling firm:
Medline Industries, LP
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.

ALL 50 STATES
▸Full report

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.

ALL 50 STATES
▸Full report

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

ALL 50 STATES
▸Full report

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

ALL 50 STATES
▸Full report

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 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

ALL 50 STATES
▸Full report

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 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)
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

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-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)
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

ALL 50 STATES
▸Full report

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)
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

ALL 50 STATES
▸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

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.

ALL 50 STATES
▸Full report

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

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.

ALL 50 STATES
▸Full report

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 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

ALL 50 STATES
▸Full report

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

ALL 50 STATES
▸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

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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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
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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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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
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

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

Recall #:
98112
Lot/product code:
Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041 MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708 MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894 MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175 MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314 MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354 MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719 MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553 MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579 MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918 MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122 MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387 MRT-3010/A5 MEXL-3010/A5 A5B11Y2005 351452 MRT-3010/A5 MEXL-3010/A5 A5C1262013 356865 MRT-3010/A5 MEXL-3010/A5 A5C1292015 378015 MRT-3010/A5 MEXL-3010/A5 A5C1412028 383946 MRT-3010/A5 MEXL-3010/A5 A5E1522033 389630 MRT-3010/A5 MEXL-3010/A5 A5D1362021 390397
Recalling firm:
Canon Medical System, USA, INC.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

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

Recall #:
98237
Lot/product code:
Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;
Recalling firm:
Boston Scientific Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Alphenix INFX-8000F, interventional fluoroscopic x-ray system

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

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

Recall #:
97970
Lot/product code:
serial numbers: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A2052056, A2A2062062, A2A2072075, A2A2042041, A1C19Z2181, W2A1092163, A2A2012005, A2A20Y2147, A1C19Y2161, B2A1612289, W4A1112030, W2A0982042, B2B18X2802, B2A1712503, B2A1712499, B2A14Z2084.
Recalling firm:
Canon Medical System, USA, INC.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

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

Recall #:
98168
Lot/product code:
1. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
Recalling firm:
ICU Medical Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No

The supplier manufactured anatomical left plates with an incorrect thread orientation.

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

Recall #:
98214
Lot/product code:
Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
Recalling firm:
Tyber Medical
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