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Recalls affecting Hawaii

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

16,303 recalls found
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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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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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

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.

Potential for fraying on the body support strap.

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

Recall #:
98140
Lot/product code:
Model/Catalog Number: K320. ID Codes: K32020130515AA, K32020130603AA, K32020130606AA, K32020130607AB, K32020130610AA, K32020130612AA, K32020130617AA, K32020130617AB, K32020130618AA, K32020130709AA, K32020130713AA, K32020130713AB, K32020130717AB, K32020130802AA, K32020130805AA, K32020130807AA, K32020130808AA, K32020130808AB, K32020130812AA, K32020130812AB, K32020130812AC, K32020130812AD, K32020130813AA, K32020130814AA, K32020130820AA, K32020130822AA, K32020130823AA, K32020130824AA, K32020130827AA, K32020130827AB, K32020130828AA, K32020130830AA, K32020130907AA, K32020130909AB, K32020130909AC, K32020130909AD, K32020130909AE, K32020130919AA, K32020130920AA, K32020130924AA, K32020131007AA, K32020131007AB, K32020131009AA, K32020131017AB, K32020131021AA, K32020131022AB, K32020131022AC, K32020131022AD, K32020131024AA, K32020131025AA, K32020131029AA, K32020131031AA, K32020131101AA, K32020131102AA, K32020131107AA, K32020131115AD, K32020131119AA, K32020131120AD, K32020131205AA, K32020131210AA, K32020131217AD, K32020140103AA, K32020140113AA, K32020140115AA, K32020140117AA, K32020140121AA, K32020140122AA, K32020140122AB, K32020140125AA, K32020140130AB, K32020140210AA, K32020140218AA, K32020140218AB, K32020140220AA, K32020140221AA, K32020140224AA, K32020140304AA, K32020140305AB, K32020140312AA, K32020140315AA, K32020140327AA, K32020140327AC, K32020140401AA, K32020140407AA, K32020140407AB, K32020140408AA, K32020140412AA, K32020140415AA, K32020140417AA, K32020140422AA, K32020140423AA, K32020140426AA, K32020140429AA, K32020140514AB, K32020140516AA, K32020140516AB, K32020140519AA, K32020140519AB, K32020140520AA, K32020140520AB, K32020140523AA, K32020140528AA, K32020140528AB, K32020140530AA, K32020140530AB, K32020140530AC, K32020140604AA, K32020140607AA, K32020140619AA, K32020140619AB, K32020140620AB, K32020140624AB, K32020140626AA, K32020140711AB, K32020140712AA, K32020140719AA, K32020140721AA, K32020140722AA, K32020140722AB, K32020140725AA, K32020140728AA, K32020140730AC, K32020140802AA, K32020140805AA, K32020140812AA, K32020140812AB, K32020140815AA, K32020140827AA, K32020140902AA, K32020140906AA, K32020140913AB, K32020140915AB, K32020140917AA, K32020140918AA, K32020140923AA, K32020140923AB, K32020140924AA, K32020140929AA, K32020140930AA, K32020141006AA, K32020141006AB, K32020141006AC, K32020141008AA, K32020141014AA, K32020141021AA, K32020141028AA, K32020141030AA, K32020141031AA, K32020141101AB, K32020141107AA, K32020141107AB, K32020141113AA, K32020141113AB, K32020141118AD, K32020141120AA, K32020141121AA, K32020141121AB, K32020141124AA, K32020141128AA, K32020141203AA, K32020141209AA, K32020141209AC, K32020141213AA, K32020141215AA, K32020141215AB, K32020141215AC, K32020141215AD, K32020141229AA, K32020141229AB, K32020141229AC, K32020150102AA, K32020150112AA, K32020150123AA, K32020150128AA, K32020150128AB, K32020150128AC, K32020150129AA, K32020150130AA, K32020150130AB, K32020150130AC, K32020150202AA, K32020150203AA, K32020150207AB, K32020150207AC, K32020150211AA, K32020150211AC, K32020150221AA, K32020150226AB, K32020150227AA, K32020150302AA, K32020150303AA, K32020150304AA, K32020150304AB, K32020150309AA, K32020150312AA, K32020150312AB, K32020150319AA, K32020150323AA, K32020150323AB, K32020150325AA, K32020150325AB, K32020150330AA, K32020150331AA, K32020150331AB, K32020150331AC, K32020150331AD, K32020150415AA, K32020150415AB, K32020150415AC, K32020150415AD, K32020150416AA, K32020150416AB, K32020150417AA, K32020150418AB, K32020150421AA, K32020150421AB, K32020150421AC, K32020150421AD, K32020150423AA, K32020150427AB, K32020150430AA, K32020150430AB, K32020150506AA, K32020150506AC, K32020150508AA, K32020150518AB, K32020150519AA, K32020150519AB, K32020150519AC, K32020150521AA, K32020150601AA, K32020150602AA, K32020150602AB, K32020150609AA, K32020150609AB, K32020150609AC, K32020150610AA, K32020150612AA, K32020150615AA, K32020150619AB, K32020150620AA, K32020150622AA, K32020150622AB, K32020150626AB, K32020150629AB, K32020150701AA, K32020150704AA, K32020150709AA, K32020150710AA, K32020150711AA, K32020150714AA, K32020150715AA, K32020150717AA, K32020150720AA, K32020150721AA, K32020150723AA, K32020150724AB, K32020150727AA, K32020150801AA, K32020150803AA, K32020150805AB, K32020150806AA, K32020150807AA, K32020150811AB, K32020150818AA, K32020150818AB, K32020150818AC, K32020150819AA, K32020150819AC, K32020150822AA, K32020150824AA, K32020150824AB, K32020150825AA, K32020150826AA, K32020150831AA, K32020150901AA, K32020150901AC, K32020150901AD, K32020150909AA, K32020150911AA, K32020150915AA, K32020150915AB, K32020150922AA, K32020150922AB, K32020150922AC, K32020150922AD, K32020150925AA, K32020150925AB, K32020151001AA, K32020151003AB, K32020151003AC, K32020151009AA, K32020151010AA, K32020151012AA, K32020151012AC, K32020151023AA, K32020151027AA, K32020151027AB, K32020151031AA, K32020151102AA, K32020151102AB, K32020151104AA, K32020151107AA, K32020151109AA, K32020151112AA, K32020151112AB, K32020151116AA, K32020151120AA, K32020151123AA, K32020151124AA, K3… (truncated, 17749 characters total — see the official FDA record for the full value)
Recalling firm:
Community Products, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

ALL 50 STATES
▸Full report

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

Recall #:
98338
Lot/product code:
All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P50E-B, 5037881167015; 632520PE, 632520PE-B, 5037881166773; 632412PE, 632412PE-B, 5037881166988; 631510PE, 631510PE-B, 5037881166834; 635022PE, 635022PE-B, 5037881166629; 631224PE, 631224PE-B, 5037881166902; 632412P50E, 632412P50E-B, 5037881167053; 631507PE, 631507PE-B, 5037881166810; 633014PE, 633014PE-B, 5037881166735; 632010P50E, 632010P50E-B, 5037881167039; 635020PE, 635020PE-B, 5037881166612; 631809P50E, 631809P50E-B, 5037881167022. All Gelweave devices (any item number ending E-B e.g. 7320128/10RMEE-B); REF, Item Number, UDI-DI(GTIN): 736038E, 736038E-B, 5037881169415; 736036E, 736036E-B, 5037881169408; 736034E, 736034E-B, 5037881169392; 736032ST/10DE, 736032ST/10DE-B, 5037881172620; 736032E, 736032E-B, 5037881169385; 736030ST/10DE, 736030ST/10DE-B, 5037881172637; 736030E , 736030E-B, 5037881169378; 736028ST/10DE, 736028ST/10DE-B, 5037881172644; 736028E, 736028E-B, 5037881169361; 736026ST/10DE, 736026ST/10DE-B, 5037881172651; 736026E, 736026E-B, 5037881169354; 736024ST/10DE, 736024ST/10DE-B, 5037881172668; 736024E, 736024E-B, 5037881169347; 736022ST/10DE, 736022ST/10DE-B, 5037881172675; 736022E, 736022E-B, 5037881169330; 736020E, 736020E-B, 5037881169323; 736018E, 736018E-B, 5037881169316; 736016E, 736016E-B, 5037881114057; 736014E, 736014E-B, 5037881114040; 736012E, 736012E-B, 5037881168548; 736010E, 736010E-B, 5037881168517; 736008E, 736008E-B, 5037881168494; 736006E, 736006E-B, 5037881166056; 735034ST/8AE, 735034ST/8AE-B, 5037881173061; 735034/8RME, 735034/8RME-B, 5037881170039; 735034/10SEE, 735034/10SEE-B, 5037881171883; 735034/10RME, 735034/10RME-B, 5037881169958; 735032STE, 735032STE-B, 5037881175102; 735032ST/8AE, 735032ST/8AE-B, 5037881173078; 735032/8SE, 735032/8SE-B, 5037881172095; 735032/8RME, 735032/8RME-B, 5037881170046; 735032/10SEE, 735032/10SEE-B, 5037881171890; 735032/10RME, 735032/10RME-B, 5037881169965; 735030STE, 735030STE-B, 5037881175126; 735030ST/8AE, 735030ST/8AE-B, 5037881173085; 735030/8SE, 735030/8SE-B, 5037881172101; 735030/8RME, 735030/8RME-B, 5037881170053; 735030/10SEE, 735030/10SEE-B, 5037881171906; 735030/10RME, 735030/10RME-B, 5037881169972; 735028STE, 735028STE-B, 5037881175133; 735028ST/8AE, 735028ST/8AE-B, 5037881173092; 735028E, 735028E-B 5037881168876; 735028/8SE, 735028/8SE-B, 5037881172118; 735028/8RME, 735028/8RME-B, 5037881170060; 735028/10RME, 735028/10RME-B, 5037881169989; 735026STE, 735026STE-B, 5037881175140; 735026ST/8AE, 735026ST/8AE-B, 5037881173108; 735026E, 735026E-B, 5037881168869; 735026/8SE, 735026/8SE-B, 5037881172125; 735026/8RME, 735026/8RME-B, 5037881170077; 735026/10RME, 735026/10RME-B, 5037881169996; 735024STE, 735024STE-B, 5037881175164; 735024ST/8AE, 735024ST/8AE-B, 5037881173115; 735024E, 735024E-B, 5037881168845; 735024/8SE, 735024/8SE-B, 5037881172132; 735024/8RME, 735024/8RME-B, 5037881170084; 735024/10SEE, 735024/10SEE-B, 5037881171937; 735024/10RME, 735024/10RME-B, 5037881170008; 735022STE, 735022STE-B, 5037881175188; 735022E, 735022E-B, 5037881168838; 735022/8SE, 735022/8SE-B, 5037881172149; 735022/8RME, 735022/8RME-B, 5037881170091; 735020E, 735020E-B, 5037881168821; 735020/8RME, 735020/8RME-B, 5037881170107; 735018E, 735018E-B, 5037881168814; 734038E, 734038E-B, 5037881169309; 734036E, 734036E-B, 5037881169293; 734034E, 734034E-B, 5037881169286; 734034CX4RMSE, 734034CX4RMSE-B, 5037881170794; 734034/8E, 734034/8E-B, 5037881172460; 734034/10E, 734034/10E-B, 5037881172224; 734032E, 734032E-B, 5037881169279; 734032CX4RMSE, 734032CX4RMSE-B, 5037881170800; 734032… (truncated, 14600 characters total — see the official FDA record for the full value)
Recalling firm:
Vascutek, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 18, 2025

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Presence of particulate matter - Glass like particles.

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▸Full report

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

Recall #:
D-0249-2026
Lot/product code:
Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 18, 2025

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

Presence of particulate matter - Glass like particles.

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▸Full report

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

Recall #:
D-0250-2026
Lot/product code:
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Recalling firm:
Imprimis NJOF, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2025

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

Lack of Assurance of Sterlity

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▸Full report

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

Recall #:
D-0243-2026
Lot/product code:
Lot #: 5086623, Exp. Date 03/31/2028
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Push-In Suture Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

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▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10S30002; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Fixone Hybrid Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

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▸Full report

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

Recall #:
98312
Lot/product code:
Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Dual Thread Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

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▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10N47502, 10N55002; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Fixone Biocomposite Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

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▸Full report

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

Recall #:
98312
Lot/product code:
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

AlternatiV+ Max Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

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▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 20KPN4751, 20KPN5501; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

AlternatiV+ Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Screw-In Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2025

Genesis Knotless Anchor

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

ALL 50 STATES
▸Full report

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

Recall #:
98312
Lot/product code:
Model No. 10KPN4751, 10KPN5501; All UDI Codes; All Lots.
Recalling firm:
Aju Pharm Co., Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

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

Recall #:
98197
Lot/product code:
REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036; REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860; REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533; REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMF861; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25CMC823; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25EBF365; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25CBM352; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25EBI642; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25DBP916; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25CBT429; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25FBR222; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25EBJ713; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25CBH758; REF CDS983393L: UDI/DI 10198459224614 (EA) 40198459224615 (CS), Lot number 25EBP657; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25CMG731; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25BME966; REF CDS984656R: UDI/DI 10198459312113 (EA) 40198459312114 (CS), Lot number 25DMI408; REF CDS984663J: UDI/DI 10198459019418 (EA) 40198459019419 (CS), Lot number 25CBM414; REF CDS985467J: UDI/DI 10195327689124 (EA) 40195327689125 (CS), Lot number 25BMF759; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25FLA112; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25ELA210; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA810; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA007; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25DLA059; REF DYNJ36840L: UDI/DI 10198459331923 (EA) 40198459331924 (CS), Lot number 25EBB131; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25FLA334; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25DLA454; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25CLA543; REF DYNJ50649J: UDI/DI 10195327261504 (EA) 40195327261505 (CS), Lot number 25CBT190; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25FDA204; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25DDB877; REF DYNJ52564D: UDI/DI 10195327176426 (EA) 40195327176427 (CS), Lot number 25BMF583; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMD560; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMI642; REF DYNJ52581D: UDI/DI 10195327213886 (EA) 40195327213887 (CS), Lot number 25DMB242; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25EMI041; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25DMG684; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25CMD347; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25FMD297; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMH371; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMA836; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMH615; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMA935; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25FBD162; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBV003; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBO450; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBB005; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBS192; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBB252; REF DYNJ62136B: UDI/DI 1019845… (truncated, 20181 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060 8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054 9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037 10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032 11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039 12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041 13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018 14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040 15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

25GA Subretinal Injection Cannula VS0220.25

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

ALL 50 STATES
▸Full report

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

Recall #:
98197
Lot/product code:
REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095; REF DYNJ902030J: UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371; REF DYNJ905274D: UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453; REF DYNJ910634: UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Tecfen Retractable Membrane Polisher, QTPR1267-23

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 817618024508 Box UDI 817618024508 Lot 2411013
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 5060720920298 Box UDI 5060720920298 Lot 2411033
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

ALL 50 STATES
▸Full report

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

Recall #:
98255
Lot/product code:
25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017; 27GA Backflush Retractable Pouch UDI 810123480517 Box UDI 810123480791 Lot 2411016
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

ALL 50 STATES
▸Full report

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

Recall #:
98197
Lot/product code:
REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870; REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322; REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006; REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145; REF DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967; REF DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439; REF DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329; REF DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730; REF DYNJ907405C… (truncated, 6391 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

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

Recall #:
98197
Lot/product code:
1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 16, 2025

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

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

Recall #:
D-0254-2026
Lot/product code:
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Recalling firm:
SpecGx, LLC
View official FDA record (opens in a new tab)