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Recalls affecting Oregon

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

16,620 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 Mendietary 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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa 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.

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UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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 ValueOrganic 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

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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.

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey 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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit 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

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UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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.

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UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust 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

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

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 9, 2025

Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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Full report

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

Recall #:
98383
Lot/product code:
Lot Code: 420189, Double Fenestrated Grasper GTIN: 00886874111581 FDA Medical Device Listing Number: D088920 Material Number: 420189-07 Batch / System Numbers: M10120911 SH1182 M10130103 SH1182 M10130116 SH1182 M10130124 SH1182 M10130422 SH1182 M10130731 SH1182 M10130918 SH1182 M10110112 SG704 M10110202 SG704 M10110318 SG704 M10111028 SG704 M20111221 SG704 M10120220 SG704 M10120419 SG704 M10130110 SG704 M10130422 SG704 M10130726 SG704 M10130802 SG704 M10130802 SH0547 M10130918 SH0547 M10110808 SH0059 M10111027 SH0059 M10111104 SH0059 M10121123 SH0059 M10121213 SH0059 M10130103 SH0059 M10130815 SH1557 M10130625 SH1390 M10130731 SH1390 M10130802 SH1390 M10130603 USG721 M10120911 SH0825 M10120727 SH1378 M10121026 SH1378 M10121105 SH1378 M10130121 SH1378 M10130207 SH1378 M10130218 SH1378 M10130322 SH1378 M10130315 SH1378 M10130422 SH1378 M10130603 SH1378 M10130625 SH1378 M10130726 SH1378 M10131010 SH1378 M10110309 SH0729 M10110415 SH0729 M10110621 SH0729 M10110812 SH0729 M10121009 SH0729 M10130103 SH0729 M10130124 SH1622 M10120125 SH1076 M10121113 SH1076 M10130426 SH1604 M10120719 SH1385 M10120727 SH1385 M10120822 SH1385 M10120829 SH2144 M10111104 SH0761 M10120327 SH1276 M10120522 SH1276 M10121026 SH1276 M10130514 SH1276 M10130426 USG518 M10130829 USG518 Material Number: 420189-09 Batch / System Numbers: M10131104 SH1182 M10140228 SH1182 M10140414 SH1182 N10140508 SH1182 N10140619 SH1182 N10140703 SH1182 N10140812 SH1182 N10140902 SH1182 N10141204 SH1182 N10150430 SH1182 N10150814 SH1182 N10150916 SH1182 N10151106 SH1182 N10151119 SH1182 N10160429 SH1182 N10160520 SH1182 N10150825 SH1182 N10160617 SH1182 N10160914 SH1182 N10161012 SH1182 N10161222 SH1182 N10160908 SH1182 N10180105 SH1182 N10140521 SG704 N10140801 SG704 N10141017 SG704 N10150309 SG704 N10150526 SG704 N10150805 SG704 N10160106 SG704 N10160429 SG704 N10160425 SG704 N10160901 SG704 N10170330 SG704 N10171116 SG704 N10171121 SG704 N10150219 SH0547 N10160408 SH0547 M10140324 SH0059 N10140902 SH0059 N10141121 SH0059 N10150227 SH0059 N10150409 SH0059 N10150626 SH0059 N10160901 SH0059 N10160914 SH0059 N10161012 SH0059 N10161122 SH0059 N10171212 SH0059 N10150416 SH1557 N10150727 SH1557 N10160229 SH1557 N10151201 SH1557 N10160520 SH1557 N10160817 SH1557 N10161012 SH1557 N10161122 SH1557 N10170130 SH1557 N10170210 SH1557 N10160825 SH1557 N10170515 SH1557 N10170815 SH1557 N10171116 SH1557 N10171121 SH1557 N10180105 SH1557 M10131108 SH1390 N10141017 SH1390 N10170825 SH1368 N10160525 USG721 N10160808 USG721 M10140327 SH2186 N10140902 SH0825 N10141027 SH0825 N10160114 SH0825 N10161027 SH0825 N10171116 SH0825 M10131025 SH1378 M10131104 SH1378 M10140214 SH1378 M10140324 SH1378 N10140508 SH1378 N10140902 SH1378 N10141030 SH1378 N10141204 SH1378 N10160203 SH1378 N10170330 SH1378 M10140325 SH0729 N10140711 SH0729 N10150122 SH0729 N10150910 SH0729 N10151217 SH0729 N10160509 SH0729 N10160216 SH0035 N10170609 SH0035 M10140327 SH2125 N10140603 SH2125 N10160718 SH2125 N10161209 SH2125 N10171019 SH1604 N10171220 SH1604 N10170531 SH1279 N10170609 SH1279 N10170628 SH1279 N10140711 SH2144 N10150129 SH2144 N10150526 SH2144 N10150727 SH2144 N10151119 SH2144 N10160914 SH2144 N10161222 SH2144 N10171204 SH2144 M10140414 SH1276 N10140603 SH1276 N10150129 USG518 Material Number: 420189-10 Batch / System Numbers: N10180409 SH1182 N10180702 SH1182 N10180509 SG704 N10180223 SH1557 N10180712 SH1557 N12180123 SH0825 N10180409 SH1279 Material Number: 420189-11 Batch / System Numbers: N10190128 SH1182 N10190206 SH1182 N10180814 SH1557 N10181005 SH1557 N10180802 SH1557 N10180928 SH1557 N10190423 SH1557 N10190902 SH1557 N10180814 SH0825 N10190805 SH0825 N10190306 SH2180 N10190128 SH1604 N10180814 SH2144 Material Number: 420189-12 Batch / System Numbers: N10190715 SH1182 N10190502 SH1182 N10190513 SH1182 N10190513 SH1557 N10190408 SH1557 N10190715 SH1557 N10200217 SH1557 N10200803 SH1557 N10201005 SH1557 N10210419 SH1557 N10210210 SH1557 N10200217 SH1964 N10200720 SH1964 N10200427 SH1964 N10210419 SH1964 N10210308 SH1964 N10210713 SH1964 N10200427 SH1604 N10210104 SH1604 N10190502 SH1385 N10210913 SH2144 K10220925 SH2144 K10231026 SH2144
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 9, 2025

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

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-0240-2026
Lot/product code:
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Recalling firm:
SUN PHARMA /TARO
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 9, 2025

Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.

ALL 50 STATES
Full report

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

Recall #:
98078
Lot/product code:
Lot Code: UDI-DI: 04260102136120; 04260102136151
Recalling firm:
Heraeus Medical GmbH (Dental Division)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2025

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

ALL 50 STATES
Full report

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

Recall #:
98071
Lot/product code:
Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22. 3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75, (01)00884838116740(21)33, (01)00884838116740(21)47, (01)00884838116740(21)60, (01)00884838116740(21)53, (01)00884838116740(21)45, (01)00884838116740(21)61, (01)00884838116740(21)34, (01)00884838116740(21)54, (01)00884838116740(21)35, (01)00884838116740(21)49, (01)00884838116740(21)32, (01)00884838116740(21)28, (01)00884838116740(21)27, (01)00884838116740(21)26, (01)00884838116740(21)51, (01)00884838116740(21)11, (01)00884838116740(21)20, (01)00884838116740(21)41, (01)00884838116740(21)52, (01)00884838116740(21)3. 4. Model Number: 722232. UDI Numbers: (01)00884838116757(21)61, (01)00884838116757(21)60, (01)00884838116757(21)5, (01)00884838116757(21)49, (01)00884838116757(21)2, (01)00884838116757(21)91, (01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)23, (01)00884838116757(21)43, (01)00884838116757(21)36, (01)00884838116757(21)96, (01)00884838116757(21)95, (01)00884838116757(21)10, (01)00884838116757(21)76, (01)00884838116757(21)42, (01)00884838116757(21)6, (01)00884838116757(21)77, (01)00884838116757(21)3, (01)00884838116757(21)1, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)44, (01)00884838116757(21)30, (01)00884838116757(21)29, (01)00884838116757(21)28, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)8, (01)00884838116757(21)81, (01)00884838116757(21)20, (01)00884838116757(21)16, (01)00884838116757(21)11, (01)00884838116757(21)112, (01)00884838116757(21)63, (01)00884838116757(21)68, (01)00884838116757(21)32, (01)00884838116757(21)35, (01)00884838116757(21)122, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)13, (01)00884838116757(21)50, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)4, (01)00884838116757(21)105, (01)00884838116757(21)75, (01)00884838116757(21)121, (01)00884838116757(21)120, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)73, (01)00884838116757(21)70, (01)00884838116757(21)69, (01)00884838116757(21)37. 5. Model Number: 722235. UDI Numbers: (01)00884838116788(21)88, (01)00884838116788(21)43, (01)00884838116788(21)12, (01)00884838116788(21)102, (01)00884838116788(21)127, (01)00884838116788(21)57, (01)00884838116788(21)55, (01)00884838116788(21)11, (01)00884838116788(21)76, (01)00884838116788(21)71, (01)00884838116788(21)59, (01)00884838116788(21)77, (01)00884838116788(21)89, (01)00884838116788(21)56, (01)00884838116788(21)99, (01)00884838116788(21)30, (01)00884838116788(21)84, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)93, (01)00884838116788(21)31, (01)00884838116788(21)47, (01)00884838116788(21)3, (01)00884838116788(21)13, (01)00884838116788(21)10, (01)00884838116788(21)74, (01)00884838116788(21)98, (01)00884838116788(21)40, (01)00884838116788(21)81, (01)00884838116788(21)66, (01)00884838116788(21)63, (01)00884838116788(21)67, (01)00884838116788(21)64, (01)00884838116788(21)42, (01)00884838116788(21)65, (01)00884838116788(21)58, (01)00884838116788(21)53, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)44, (01)00884838116788(21)35, (01)00884838116788(21)45, (01)00884838116788(21)39, (01)00884838116788(21)25, (01)00884838116788(21)34, (01)00884838116788(21)17, (01)00884838116788(21)24, (01)00884838116788(21)19, (01)00884838116788(21)33, (01)00884838116788(21)18, (01)00884838116788(21)9, (01)00884838116788(21)28, (01)00884838116788(21)8, (01)008848381… (truncated, 26641 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 December 8, 2025

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

ALL 50 STATES
Full report

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

Recall #:
98132
Lot/product code:
Affected UDI-DI: 00857534006011 00857534006592 00857534006608 00857534006615 Affected serial numbers: 10006206 10005998 10003999 10004026 10003796 10003811 10006629 10006630 10007514 10007515 10002486 10003048 10004215 10004216 10003794 10004231 10012064 10012310 10012311 10010990 10011142 10007914 10007971 10002391 10002969 10009132 10010058 10011570 10005134 10005711 10009569 10009878 10010057 10003903 10003906 10003546 10006187 10012838 10010639 10010666 10011925 10006692 10007246 10011463 10005092 10007237 10007509 10008416 10003407 10003793 10004195 10004975 10004993 10005136 10010381 10007906 10013179 10007510 10007511 10007245 10004449 10004961 10005849 10005851 10010747 10006730 10011187 10011307 10009593 10010003 10008073 10008354 10011546 10011571 10006207 10012127 10006631 10007777 10006411 10004466 10005445 10011645 10009015 10004291 10003985 10003987 10006204 10006205 10007235 10007236 10006412 10004775 10004323 10004942 10003936 10003937 10007130 10002695 10007126 10007128 10009228 10009210 10009583 10005480 10005481 10012839 10008645 10008670 10006693 10006694 10004317 10002403 10004673 10004671 10010572 10006212 10006203 10002968 10002715 10011186 10011265 10010059
Recalling firm:
IMRIS Imaging Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusSalmonellaRecalled December 8, 2025

Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027

Potential contamination with Salmonella.

ALL 50 STATES
Full report

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

Recall #:
H-0357-2026
Lot/product code:
LOT #: PK00459
Recalling firm:
Sam Dry Fruits and Nuts Enterprises, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2025

Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.

ALL 50 STATES
Full report

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

Recall #:
98122
Lot/product code:
All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024. UDI-DI: 00840948102660; Serial Numbers:000CCC0E6CC9 000CCC0E6CC6 000CCC0E6CCC 000CCC0E6CCE 000CCC0E6CC5 000CCC0E6CD0 000CCC0E6D1F 000CCC0E6D1B 000CCC0E6D24 000CCC0E6D1C 000CCC0E6D22 000CCC0E6D01 000CCC0E6D04 000CCC0E6D19 000CCC0E6D1A 000CCC0E6D1E 000CCC0E6CC8 000CCC0E6D23 000CCC0E6CCD 000CCC0E6D1D 000CCC0E6CCB 000CCC0E6CCA 000CCC0E6CC7 000CCC0E6D20 000CCC0E6CCF 000CCC0E627E 000CCC0E6286 000CCC0E628C 000CCC0E6282 000CCC0E627C 000CCC0E6279 000CCC0E6289 000CCC0E627A 000CCC0E628E 000CCC0E627D 000CCC0E6288 000CCC0E6280 000CCC0E6284 000CCC0E6DDB 000CCC0E6D2E 000CCC0E6D28 000CCC0E6DE0 000CCC0E6D27 000CCC0E6D2C 000CCC0E6D2F 000CCC0E6DE3 000CCC0E6D2D 000CCC0E6D30 000CCC0E6DE1 000CCC0E6DD9 000CCC0E6DDF 000CCC0E6D25 000CCC0E6DDE 000CCC0E6DE4 000CCC0E6D2A 000CCC0E6D2B 000CCC0E6D29 000CCC0E6DDC 000CCC0E6DDA 000CCC0E6D26 000CCC0E6D36 000CCC0E6D32 000CCC0E6D06 000CCC0E6D33 000CCC0E6D3C 000CCC0E6D38 000CCC0E6D3B 000CCC0E6D07 000CCC0E6D05 000CCC0E6D0B 000CCC0E6D0A 000CCC0E6D0C 000CCC0E6D03 000CCC0E6D37 000CCC0E6D31 000CCC0E6D39 000CCC0E6D35 000CCC0E6D3A 000CCC0E6D34 000CCC0E6D08 000CCC0E6341 000CCC0E6D02 000CCC0E6D09 000CCC0E5B9F 000CCC0E5BD5 000CCC0E5BE0 000CCC0E6719 000CCC0E676D 000CCC0E676E 000CCC0E6DE2 000CCC0E6DDD 000CCC0E6CBC 000CCC0E6CC0 000CCC0E6CBF 000CCC0E6CBB 000CCC0E6CB9 000CCC0E6CBA 000CCC0E6D6A 000CCC0E6CC2 000CCC0E6CBE 000CCC0E6D61 000CCC0E6D67 000CCC0E6D68 000CCC0E6D62 000CCC0E6CC1 000CCC0E6D65 000CCC0E6D63 000CCC0E6CC3 000CCC0E6D66 000CCC0E6CBD 000CCC0E6CC4 000CCC0E6D64 000CCC0E6D69 000CCC0E6D6C 000CCC0E6D6B 000CCC0E6483 000CCC0E6482 000CCC0E647D 000CCC0E62A2 000CCC0E6484 000CCC0E633D 000CCC0E647A 000CCC0E647B 000CCC0E6340 000CCC0E6480 000CCC0E6481 000CCC0E647E 000CCC0E633C 000CCC0E62B6 000CCC0E647F 000CCC0E647C 000CCC0E6342 000CCC0E6343 000CCC0E633A 000CCC0E6479 000CCC0E6271 000CCC0E6278 000CCC0E6270 000CCC0E635C 000CCC0E6354 000CCC0E6353 000CCC0E6275 000CCC0E6355 000CCC0E6374 000CCC0E6357 000CCC0E6273 000CCC0E635B 000CCC0E6276 000CCC0E6352 000CCC0E626F 000CCC0E6358 000CCC0E6274 000CCC0E635A 000CCC0E626D 000CCC0E6356 000CCC0E6351 000CCC0E62A0 000CCC0E62A3 000CCC0E62A5 000CCC0E62BD 000CCC0E62C0 000CCC0E629D 000CCC0E62B5 000CCC0E62A1 000CCC0E629F 000CCC0E62B8 000CCC0E62BE 000CCC0E62BB 000CCC0E62A6 000CCC0E62BC 000CCC0E62BA 000CCC0E62A8 000CCC0E62BF 000CCC0E6277 000CCC0E6261 000CCC0E626E 000CCC0E6359 000CCC0E6265 000CCC0E6272 000CCC0E6531 000CCC0E652D 000CCC0E652E 000CCC0E6535 000CCC0E62EF 000CCC0E6537 000CCC0E6532 000CCC0E6530 000CCC0E6536 000CCC0E6538 000CCC0E652F 000CCC0E6533 000CCC0E6534 000CCC0E64E4 000CCC0E64DD 000CCC0E64DB 000CCC0E64DF 000CCC0E64DE 000CCC0E64E1 000CCC0E6329 000CCC0E632A 000CCC0E64D9 000CCC0E632C 000CCC0E6325 000CCC0E6326 000CCC0E64E2 000CCC0E6322 000CCC0E64E0 000CCC0E64E3 000CCC0E6327 000CCC0E6328 000CCC0E632B 000CCC0E64DC 000CCC0E64DA 000CCC0E6324 000CCC0E6323 000CCC0E6321 000CCC0E6469 000CCC0E62F6 000CCC0E6465 000CCC0E62F1 000CCC0E62F4 000CCC0E62F9 000CCC0E646A 000CCC0E62F5 000CCC0E62F3 000CCC0E646C 000CCC0E6468 000CCC0E6466 000CCC0E62F7 000CCC0E62FC 000CCC0E6464 000CCC0E6462 000CCC0E62FA 000CCC0E6467 000CCC0E62F2 000CCC0E6461 000CCC0E62FB 000CCC0E646B 000CCC0E62F8 000CCC0E6463 000CCC0E648D 000CCC0E648E 000CCC0E6486 000CCC0E64A2 000CCC0E6488 000CCC0E6487 000CCC0E64A8 000CCC0E648C 000CCC0E64A3 000CCC0E648A 000CCC0E649E 000CCC0E648F 000CCC0E649F 000CCC0E64A5 000CCC0E6490 000CCC0E6485 000CCC0E64A0 000CCC0E64A4 000CCC0E64A1 000CCC0E649D 000CCC0E64A6 000CCC0E6489 000CCC0E648B 000CCC0E64A7 000CCC0E626C 000CCC0E6268 000CCC0E626B 000CCC0E6371 000CCC0E6267 000CCC0E6373 000CCC0E636A 000CCC0E636B 000CCC0E6266 000CCC0E636F 000CCC0E6263 000CCC0E6370 000CCC0E636D 000CCC0E626A 000CCC0E6264 000CCC0E6369 000CCC0E6269 000CCC0E636E 000CCC0E636C 000CCC0E62F0 000CCC0E62E6 000CCC0E62EC 000CCC0E62C2 000CCC0E62E8 000CCC0E62ED 000CCC0E62C4 000CCC0E62E5 000CCC0E6258 000CCC0E64CD 000CCC0E64D0 000CCC0E64CE 000CCC0E64D8 000CCC0E64D5 000CCC0E64D2 000CCC0E64D7 000CCC0E6491 000CCC0E64D3 000CCC0E649C 000CCC0E64CF 000CCC0E64D4 000CCC0E64D1 000CCC0E64D6 000CCC0E625E 000CCC0E6260 000CCC0E625F 000CCC0E625B 000CCC0E62C7 000CCC0E62EE 000CCC0E62C6 000CCC0E62C1 000CCC0E62C3 000CCC0E62C5 000CCC0E62E9 000CCC0E62CB 000CCC0E6259 000CCC0E61D4 000CCC0E6256 000CCC0E61D8 000CCC0E625A 000CCC0E61D6 000CCC0E625D 000CCC0E61D2 000CCC0E6257 000CCC0E61D5 000CCC0E61D7 000CCC0E61DA 000CCC0E625C 000CCC0E61D9 000CCC0E61DB 000CCC0E61D3 000CCC0E61D1 000CCC0E6255 000CCC0E61C6 000CCC0E61DC 000CCC0E649A 000CCC0E6498 000CCC0E649B 000CCC0E6493 000CCC0E6499 000CCC0E6497 000CCC0E6494 000CCC0E6492 000CCC0E6496 000CCC0E6495 000CCC0E633E 000CCC0E633F 000CCC0E6339 000CCC0E6344 000CCC0E633B 000CCC0E61CB 000CCC0E61CF 000CCC0E6230 000CCC0E6227 000CCC0E61C8 000CCC0E6226 000CCC0E6228 000CCC0E61C9 000CCC0E61C7 000CCC0E61C5 000CCC0E6229 000CCC0E61CE 000CCC0E622F 000CCC0E61CD 000CCC0E6141 000CCC0E6146 000CCC0E6144 000CCC0E6209 000CCC0E614B 000CCC0E6206 000CCC0E620A 000CCC… (truncated, 24805 characters total — see the official FDA record for the full value)
Recalling firm:
Securitas Healthcare LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2025

The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.

Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).

Full report

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

Recall #:
98094
Lot/product code:
REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.
Recalling firm:
Beckman Coulter Ireland, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 8, 2025

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.

ALL 50 STATES
Full report

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

Recall #:
98122
Lot/product code:
All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024. UDI-DI: 00840948102653; Serial Numbers: 000CCC0E68FE 000CCC0E6901 000CCC0E6907 000CCC0E68FF 000CCC0E6638 000CCC0E6905 000CCC0E68FD 000CCC0E6904 000CCC0E6908 000CCC0E69AD 000CCC0E6902 000CCC0E69AE 000CCC0E69A9 000CCC0E69A8 000CCC0E6639 000CCC0E6903 000CCC0E69AA 000CCC0E6900 000CCC0E69A6 000CCC0E6B16 000CCC0E6B0D 000CCC0E6B12 000CCC0E6B20 000CCC0E6B10 000CCC0E6B1C 000CCC0E6B21 000CCC0E6B14 000CCC0E6B0C 000CCC0E6B1A 000CCC0E6B11 000CCC0E6B1F 000CCC0E6B22 000CCC0E6B15 000CCC0E6B0E 000CCC0E6B0F 000CCC0E69A5 000CCC0E69AC 000CCC0E69A3 000CCC0E69AB 000CCC0E69A4 000CCC0E6B17 000CCC0E6B19 000CCC0E6B0B 000CCC0E6B1E 000CCC0E6B13 000CCC0E6B18 000CCC0E6B1D 000CCC0E6B1B 000CCC0E6ACA 000CCC0E6ACB 000CCC0E6ABF 000CCC0E6AC4 000CCC0E6AAF 000CCC0E6ABB 000CCC0E6AB8 000CCC0E6ABD 000CCC0E6AB7 000CCC0E6ABE 000CCC0E6AC2 000CCC0E6ABA 000CCC0E6A5D 000CCC0E6A74 000CCC0E6A61 000CCC0E6A57 000CCC0E6A58 000CCC0E6A5C 000CCC0E6A62 000CCC0E6A79 000CCC0E6A6F 000CCC0E6A5B 000CCC0E6A5E 000CCC0E6A59 000CCC0E6A78 000CCC0E6B2C 000CCC0E6B26 000CCC0E6B24 000CCC0E6B35 000CCC0E6B3A 000CCC0E6B28 000CCC0E6B2E 000CCC0E6B29 000CCC0E6B31 000CCC0E6B23 000CCC0E6B2A 000CCC0E6B34 000CCC0E6B38 000CCC0E6B36 000CCC0E6B27 000CCC0E6B33 000CCC0E6B39 000CCC0E6B25 000CCC0E6B2D 000CCC0E6B2B 000CCC0E6B32 000CCC0E6B2F 000CCC0E6B37 000CCC0E6B30 000CCC0E6A6C 000CCC0E6A6B 000CCC0E6948 000CCC0E6A67 000CCC0E6637 000CCC0E6946 000CCC0E6945 000CCC0E6947 000CCC0E6A68 000CCC0E6636 000CCC0E6A66 000CCC0E694D 000CCC0E6949 000CCC0E6A63 000CCC0E694F 000CCC0E694B 000CCC0E6A6D 000CCC0E6A69 000CCC0E694C 000CCC0E6A65 000CCC0E6A6A 000CCC0E6950 000CCC0E6A6E 000CCC0E694A 000CCC0E6A1E 000CCC0E6A50 000CCC0E6A24 000CCC0E6A4F 000CCC0E6A1F 000CCC0E6AD2 000CCC0E6A25 000CCC0E6A4C 000CCC0E6AD4 000CCC0E6AD7 000CCC0E6AC6 000CCC0E6ACD 000CCC0E6AC3 000CCC0E6ACE 000CCC0E6AC8 000CCC0E6AD9 000CCC0E6ADA 000CCC0E6AD0 000CCC0E6AD5 000CCC0E6AD8 000CCC0E6ACC 000CCC0E6AC7 000CCC0E6AD6 000CCC0E6AD3 000CCC0E6AC9 000CCC0E6AC5 000CCC0E6AD1 000CCC0E6ACF 000CCC0E6DCD 000CCC0E6DCE 000CCC0E6DAA 000CCC0E6DAC 000CCC0E6DB4 000CCC0E6DD0 000CCC0E6DAF 000CCC0E6DD6 000CCC0E6DB0 000CCC0E6DA9 000CCC0E6DB2 000CCC0E6DD7 000CCC0E6DB3 000CCC0E6DD1 000CCC0E6DB1 000CCC0E6DD2 000CCC0E6DAD 000CCC0E6DD4 000CCC0E6A4D 000CCC0E6DD5 000CCC0E6DCF 000CCC0E6DAE 000CCC0E6B68 000CCC0E6E27 000CCC81812355 000CCC0E6E2E 000CCC0E6E2A 000CCC0E6E2D 000CCC0E6E36 000CCC0E6E29 000CCC0E6E2F 000CCC0E6CDA 000CCC0E6CD3 000CCC0E6DF5 000CCC0E6B5F 000CCC0E6B66 000CCC0E6B60 000CCC0E6B61 000CCC0E6A64 000CCC0E6CD2 000CCC0E6B64 000CCC0E6B62 000CCC0E6CD1 000CCC0E6CDB 000CCC0E6B63 000CCC0E6CD9 000CCC0E6CD6 000CCC0E6CD5 000CCC0E6CD4 000CCC0E6B67 000CCC0E6B65 000CCC0E6CD8 000CCC0E6CDC 000CCC0E6D80 000CCC0E6D9B 000CCC0E6D93 000CCC0E6D7B 000CCC0E6D82 000CCC0E6D9C 000CCC0E6D98 000CCC0E6D9A 000CCC0E6D81 000CCC0E6D79 000CCC0E6D7A 000CCC0E6D84 000CCC0E6D7E 000CCC0E6D91 000CCC0E6D7C 000CCC0E6D92 000CCC0E6D99 000CCC0E6D7D 000CCC0E6D97 000CCC0E6D95 000CCC0E6D96 000CCC0E6D7F 000CCC0E6D83 000CCC0E6D94 000CCC0E6E26 000CCC0E6E34 000CCC0E6E35 000CCC0E6E38 000CCC0E6E33 000CCC0E6E31 000CCC0E6E3B 000CCC0E6E2B 000CCC0E6E32 000CCC0E6E30 000CCC0E6E2C 000CCC0E6E28 000CCC0E6E39 000CCC0E6E3D 000CCC0E6E3C 000CCC0E6E37 000CCC0E6DAB 000CCC0E6DD8 000CCC0E6DD3 000CCC0E6CD7 000CCC0E6D89 000CCC0E6D8D 000CCC0E6D8E 000CCC0E6D78 000CCC0E6D76 000CCC0E6D90 000CCC0E6D8F 000CCC0E6D75 000CCC0E6D8B 000CCC0E6D74 000CCC0E6D6D 000CCC0E6D71 000CCC0E6D6F 000CCC0E6D85 000CCC0E6D8C 000CCC0E6D87 000CCC0E6D72 000CCC0E6D6E 000CCC0E6D70 000CCC0E6D88 000CCC0E6D86 000CCC0E6D73 000CCC0E6D77 000CCC0E6DB6 000CCC0E6DB9 000CCC0E6D54 000CCC0E6DB5 000CCC0E6D52 000CCC0E6D4B 000CCC0E6D4E 000CCC0E6DB8 000CCC0E6DBD 000CCC0E6DB7 000CCC0E6D4F 000CCC0E6DBE 000CCC0E6D53 000CCC0E6DBF 000CCC0E6D49 000CCC0E6DBA 000CCC0E6DBB 000CCC0E6DC0 000CCC0E6D4D 000CCC0E6DBC 000CCC0E6D50 000CCC0E6D4C 000CCC0E6D4A 000CCC0E6D51 000CCC0E6DA8 000CCC0E6DC7 000CCC0E6DC3 000CCC0E6DA7 000CCC0E6DC9 000CCC0E6DA3 000CCC0E6DC1 000CCC0E6DC6 000CCC0E6DA5 000CCC0E6DC5 000CCC0E6DA1 000CCC0E6D9E 000CCC0E6DCB 000CCC0E6DCA 000CCC0E6D9F 000CCC0E6DC2 000CCC0E6D9D 000CCC0E6DA4 000CCC0E6DA6 000CCC0E6DA2 000CCC0E6DA0 000CCC0E6DC8 000CCC0E6DCC 000CCC0E6DC4 000CCC0E6D13 000CCC0E6D5C 000CCC0E6D5B 000CCC0E6D14 000CCC0E6D18 000CCC0E6D16 000CCC0E6D5D 000CCC0E6D59 000CCC0E6D55 000CCC0E6D10 000CCC0E6D58 000CCC0E6D60 000CCC0E6D12 000CCC0E6D0F 000CCC0E6D5A 000CCC0E6D57 000CCC0E6D11 000CCC0E6D5F 000CCC0E6D56 000CCC0E6D5E 000CCC0E6D17 000CCC0E6D0D 000CCC0E6D0E 000CCC0E6D15 000CCC0E68C7 000CCC0E68F0 000CCC0E68C2 000CCC0E68E9 000CCC0E68E8 000CCC0E68C1 000CCC0E68E7 000CCC0E68C8 000CCC0E68EA 000CCC0E68C3 000CCC0E68EC 000CCC0E68C6 000CCC0E68EE 000CCC0E68CA 000CCC0E68E6 000CCC0E6934 000CCC0E6941 000CCC0E6943 000CCC0E693F 000CCC0E693A 000CCC0E6940 000CCC0E6944 000CCC0E6935 000CCC0E693C 000CCC0E693B 000CCC0E693E 000CCC0E6933 000CCC0E692D 000CCC0E6932 000CCC0E6937 000CCC0E6942 000CCC0E6939 000CCC0E692F 000… (truncated, 73286 characters total — see the official FDA record for the full value)
Recalling firm:
Securitas Healthcare LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2025

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

The affected lots show a decline in performance over time, which may lead to false-negative results.

ALL 50 STATES
Full report

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

Recall #:
98038
Lot/product code:
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Recalling firm:
Meridian Bioscience Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2025

Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

Incorrect expiration date

ALL 50 STATES
Full report

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

Recall #:
98218
Lot/product code:
Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ
Recalling firm:
LimFlow, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2025

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

ALL 50 STATES
Full report

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

Recall #:
98076
Lot/product code:
Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.
Recalling firm:
Beaver-Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 5, 2025

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

ALL 50 STATES
Full report

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

Recall #:
98230
Lot/product code:
(01)04056869269931(21)10330
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
Reference Number/UDI Number/Lot Number(s) ENDO-AN2030/B 00884450645161 I2559664 00884450645161 I2617758 00884450645161 I2622046 00884450645161 I2657805 00884450645161 I2937082 00884450645161 I3056430 00884450645161 I3085664 00884450645161 I3118225 00884450645161 I3251180 00884450645161 I3282751 IN4130/CNK 00884450636695 I2559550 00884450636695 I2559551 00884450636695 I2563338 00884450636695 I2563339 00884450636695 I2563340 00884450636695 I2564655 00884450636695 I2564665 00884450636695 I2567481 00884450636695 I2567482 00884450636695 I2567483 00884450636695 I2578099 00884450636695 I2578100 00884450636695 I2584021 00884450636695 I2584024 00884450636695 I2584025 00884450636695 I2584026 00884450636695 I2607299 00884450636695 I2607301 00884450636695 I2607302 00884450636695 I2617759 00884450636695 I2617760 00884450636695 I2628998 00884450636695 I2629000 00884450636695 I2629001 00884450636695 I2629002 00884450636695 I2630702 00884450636695 I2648658 00884450636695 I2648659 00884450636695 I2648660 00884450636695 I2648661 00884450636695 I2657828 00884450636695 I2657833 00884450636695 I2657884 00884450636695 I2657889 00884450636695 I2663025 00884450636695 I2663026 00884450636695 I2663027 00884450636695 I2669899 00884450636695 I2669900 00884450636695 I2674531 00884450636695 I2674532 00884450636695 I2682701 00884450636695 I2682702 00884450636695 I2684463 00884450636695 I2684522 00884450636695 I2684523 00884450636695 I2699591 00884450636695 I2699592 00884450636695 I2703002 00884450636695 I2703003 00884450636695 I2703004 00884450636695 I2703006 00884450636695 I2703081 00884450636695 I2703082 00884450636695 I2703083 00884450636695 I2707735 00884450636695 I2707736 00884450636695 I2715012 00884450636695 I2715013 00884450636695 I2719928 00884450636695 I2719929 00884450636695 I2719930 00884450636695 I2719931 00884450636695 I2719933 00884450636695 I2752077 00884450636695 I2752078 00884450636695 I2755218 00884450636695 I2755219 00884450636695 I2755496 00884450636695 I2760565 00884450636695 I2773971 00884450636695 I2773972 00884450636695 I2784600 00884450636695 I2784603 00884450636695 I2844301 00884450636695 I2853612 00884450636695 I2853613 00884450636695 I2853615 00884450636695 I2858649 00884450636695 I2858650 00884450636695 I2858651 00884450636695 I2869290 00884450636695 I2886413 00884450636695 I2886423 00884450636695 I2886429 00884450636695 I2886432 00884450636695 I2887831 00884450636695 I2887832 00884450636695 I2887836 00884450636695 I2888430 00884450636695 I2892032 00884450636695 I2892033 00884450636695 I2894577 00884450636695 I2902444 00884450636695 I2902445 00884450636695 I2902446 00884450636695 I2902447 00884450636695 I2903533 00884450636695 I2903535 00884450636695 I2917165 00884450636695 I2917167 00884450636695 I2921904 00884450636695 I2921905 00884450636695 I2927911 00884450636695 I2933517 00884450636695 I2937693 00884450636695 I2937694 00884450636695 I2971987 00884450636695 I2973163 00884450636695 I2973184 00884450636695 I2976519 00884450636695 I2976520 00884450636695 I2976521 00884450636695 I2983704 00884450636695 I2986048 00884450636695 I2986049 00884450636695 I2989136 00884450636695 I2989137 00884450636695 I3001128 00884450636695 I3001129 00884450636695 I3001130 00884450636695 I3001131 00884450636695 I3013083 00884450636695 I3013085 00884450636695 I3014308 00884450636695 I3014309 00884450636695 I3014311 00884450636695 I3014312 00884450636695 I3044881 00884450636695 I3048387 00884450636695 I3056432 00884450636695 I3056433 00884450636695 I3067548 00884450636695 I3067549 00884450636695 I3072605 00884450636695 I3074753 00884450636695 I3074754 00884450636695 I3074755 00884450636695 I3074756 00884450636695 I3079091 00884450636695 I3079092 00884450636695 I3079093 00884450636695 I3079094 00884450636695 I3079095 00884450636695 I3079096 00884450636695 I3085666 00884450636695 I3085667 00884450636695 I3085668 00884450636695 I3097690 00884450636695 I3097691 00884450636695 I3098952 00884450636695 I3098953 00884450636695 I3098955 00884450636695 I3118226 00884450636695 I3118227 00884450636695 I3118228 00884450636695 I3118230 00884450636695 I3129660 00884450636695 I3129661 00884450636695 I3129662 00884450636695 I3129663 00884450636695 I3129664 00884450636695 I3146015 00884450636695 I3146016 00884450636695 I3150024 00884450636695 I3150025 00884450636695 I3150028 00884450636695 I3150029 00884450636695 I3161167 00884450636695 I3161168 00884450636695 I3161169 00884450636695 I3161170 00884450636695 I3186043 00884450636695 I3186044 00884450636695 I3186047 00884450636695 I3186048 00884450636695 I3186064 00884450636695 I3186065 00884450636695 I3204095 00884450636695 I3204096 00884450636695 I3204119 00884450636695 I3204120 00884450636695 I3204124 00884450636695 I3213949 00884450636695 I3232111 00884450636695 I3232118 00884450636695 I3232119 008844506… (truncated, 29818 characters total — see the official FDA record for the full value)
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

ALL 50 STATES
Full report

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

Recall #:
98157
Lot/product code:
UDI-DI (GTIN): 00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257 Serial/Lot numbers C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325
Recalling firm:
Medtronic Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

ALL 50 STATES
Full report

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

Recall #:
98099
Lot/product code:
Part No. MI-70-0128; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206183, 2232206193, 2232206203, 2232206213, 2232206223, 2232206233, 2235522143, 2235522153, 2235522163, 2236339153, 2236339163, 2236339173, 2236339183, 2303429483, 2303429503, 2313925663, 2313925673, 2316030773, 2316030783, 2316703503, 2316703523, 2317415473, 2320006923, 2320006933, 2323513413, 70-0128-13904392.
Recalling firm:
Mobius Imaging, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

ALL 50 STATES
Full report

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

Recall #:
98099
Lot/product code:
Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373, 2303430383, 2303430393, 2304034583, 2304034593, 2304034603, 2304034613, 2304034623, 2305514123, 2305514133, 2305514143, 2305514153, 2311019263, 2315101273, 2315101283, 2315101293, 2315101303, 2316030903, 2316030913, 2316703793, 2316703803, 2316703813, 2316703823, 2317415513, 2317415523, 2317415533, 2317415543, 2317415553, 2317905083, 2317905093, 2317905103, 2317905113, 2317905123, 2323513673, 2323513683, 2323513693, 2331419663, 2331419673, 2332117403, 2332117413, 2332117423, 2332117433, 2332117443, 2333404593, 2333404603, 2335506763, 2335506773, 2401909563, 2401909573, 2401909583, 2401909593, 2401909603, 2401909613, 2402911603, 2402911613, 2402911623, 2402911633, 2404302243, 2404302253, 2404302263, 2404302273, 2409620273, 2409620283, 2409620293, 2409620303, 2422207853, 2422207863, 2422207873, 2422207883, 2422207893, 2422207903, 2422207913, 2426303233, 2426303243, 2426303253, 2426303263, 2426303273, 2426303283, 2431210783, 2431210793, 2431210803, 2431210813, 2431210823, 2434504553, 2434504563, 2434504573, 2502103553, 2502103583, 2502103593, 2503121733, 2503121743, 2503121753, 2503616113, 2503616123, 2503616133, 2503616213.
Recalling firm:
Mobius Imaging, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.

Device packaged in incorrect outer box carton.

ALL 50 STATES
Full report

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

Recall #:
98086
Lot/product code:
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Allwell Angioplasty Pack REF: IS-30-B1/B

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 00884450286999 T3054879 00884450286999 T3071602 00884450286999 T3105835 00884450286999 T3128753 00884450286999 T3185484 00884450286999 T3223241 00884450286999 T3229633 00884450286999 T3276968 00884450286999 T3328128 00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647 00884450140796 T2800974 00884450140796 T2823388 00884450140796 T2853488 00884450140796 T2899143 00884450140796 T2981467 00884450140796 T2987762 00884450140796 T3022097 00884450140796 T3022100 00884450140796 T3058385 00884450140796 T3083003 00884450140796 T3121582 00884450140796 T3174127 00884450140796 T3214493 00884450140796 T3229456 00884450140796 T3297510 00884450140796 T3324542 K05T-01863: 00884450315347 T2625813 00884450315347 T2718633 00884450315347 T2762715 00884450315347 T2805459 00884450315347 T2823390 00884450315347 T2863782 00884450315347 T2910718 00884450315347 T2981470 00884450315347 T2997667 00884450315347 T3036044 00884450315347 T3070773 00884450315347 T3108821 00884450315347 T3149886S 00884450315347 T3185539 00884450315347 T3214494 00884450315347 T3216705 00884450315347 T3276914 00884450315347 T3296092 00884450315347 T3328139 K05T-01915: 00884450142882 T2643556 00884450142882 T2675575 00884450142882 T2752946 00884450142882 T2842262 00884450142882 T2893876 00884450142882 T2906056 00884450142882 T2981474 00884450142882 T2987764 00884450142882 T3070812 00884450142882 T3146178 00884450142882 T3216084 00884450142882 T3269009 00884450142882 T3322767 00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916 00884450260166 T3148674 00884450260166 T3204048 00884450260166 T3322760 K05T-01955: 00884450140826 T2643557 00884450140826 T2719601 00884450140826 T2765333 00884450140826 T2823391 00884450140826 T2861459 00884450140826 T2909930 00884450140826 T2945617 00884450140826 T2985905 00884450140826 T3070951 00884450140826 T3111451 00884450140826 T3190818 00884450140826 T3214495 00884450140826 T3278749 00884450140826 T3322843 K05T-02138: 00884450140833 T2716870 00884450140833 T2726918 00884450140833 T2745251 00884450140833 T2983353 00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335 00884450095607 T3271452 00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577 00884450684023 T2726919 00884450684023 T2759596 00884450684023 T2774653 00884450684023 T2800975 00884450684023 T2810448 00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522 00884450814710 T2898650 00884450814710 T2932783 00884450814710 T2985976 00884450814710 T2987768 00884450814710 T3043834 00884450814710 T3071604 00884450814710 T3105836 00884450814710 T3126557 00884450814710 T3185542 00884450814710 T3214496 00884450814710 T3229459 00884450814710 T3276962 00884450814710 T3309860 00884450814710 T3339469 K05T-02533: 00884450255803 T2718634 00884450255803 T2809725 00884450255803 T2849216 00884450255803 T2876922 00884450255803 T2899055 00884450255803 T2909932 00884450255803 T2981490 00884450255803 T3042476 00884450255803 T3071605 00884450255803 T3123415 00884450255803 T3181209 00884450255803 T3185434 00884450255803 T3293210 00884450255803 T3315474 00884450255803 T3336070 K05T-03153: 00884450463796 T2816275 00884450463796 T2850760 00884450463796 T2939991 00884450463796 T2985985 00884450463796 T3033317 00884450463796 T3202468 K05T-03201: 00884450547915 T2656028 00884450547915 T2690357 00884450547915 T2718635 00884450547915 T28233… (truncated, 5202 characters total — see the official FDA record for the full value)
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
UDI: 00884450320297/ Lot: T2736369 T2781930 T2898771S T3047503 T3090431 T3121937 T3146114 T3158708 T3204129 T3232415
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Allwell Inflation Device, for angiographic use REF: IS-30-A

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Full report

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

Recall #:
98215
Lot/product code:
Lot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014 Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 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(truncated, 94459 characters total — see the official FDA record for the full value)
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 4, 2025

Merit Medical , Custom Manifold Kit REF: K09-13203A

Inflation device handle may detach from the syringe during procedure.

ALL 50 STATES
Full report

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

Recall #:
98139
Lot/product code:
K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407
Recalling firm:
Merit Medical Systems, Inc.
View official FDA record (opens in a new tab)