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Recalls affecting Alabama

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

16,908 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

View FDA’s announcement (opens in a new tab)
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.

View FDA’s announcement (opens in a new tab)
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

View FDA’s announcement (opens in a new tab)
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

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
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.

View FDA’s announcement (opens in a new tab)
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

View FDA’s announcement (opens in a new tab)
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.

View FDA’s announcement (opens in a new tab)
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

View FDA’s announcement (opens in a new tab)
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 19, 2025

SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98206
Lot/product code:
Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

ALL 50 STATES
Full report

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

Recall #:
98123
Lot/product code:
Lot AZ4824290
Recalling firm:
Tornier, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 19, 2025

NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98206
Lot/product code:
Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Rifton Equipment, TRAM. Model/Catalog Number: K310. 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.

Potential for fraying on the body support strap.

ALL 50 STATES
Full report

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

Recall #:
98140
Lot/product code:
Model/Catalog Number: K310. ID Codes: K31020120704AA, K31020120706AA, K31020120707AC, K31020120707AD, K31020120707AE, K31020120707AG, K31020120709AA, K31020120709AB, K31020120709AD, K31020120709AE, K31020120710AB, K31020120710AE, K31020120711AB, K31020120712AA, K31020120713AB, K31020120713AC, K31020120713AD, K31020120713AF, K31020120718AA, K31020120718AB, K31020120718AC, K31020120719AC, K31020120720AA, K31020120801AA, K31020120804AB, K31020120804AD, K31020120804AH, K31020120804AI, K31020120806AA, K31020120806AC, K31020120806AD, K31020120806AE, K31020120806AG, K31020120806AH, K31020120806AI, K31020120806AL, K31020120806AM, K31020120806AN, K31020120806AO, K31020120807AA, K31020120807AB, K31020120807AC, K31020120807AE, K31020120807AF, K31020120809AD, K31020120809AE, K31020120810AC, K31020120813AB, K31020120814AA, K31020120814AB, K31020120814AC, K31020120816AA, K31020120816AC, K31020120816AD, K31020120817AB, K31020120817AC, K31020120820AC, K31020120820AD, K31020120821AA, K31020120821AB, K31020120821AC, K31020120821AD, K31020120822AC, K31020120824AA, K31020120824AB, K31020120824AC, K31020120827AC, K31020120828AA, K31020120828AB, K31020120829AA, K31020120830AC, K31020120831AB, K31020120831AC, K31020120831AD, K31020120903AB, K31020120903AC, K31020120904AC, K31020120906AC, K31020120906AD, K31020120906AE, K31020120907AA, K31020120911AA, K31020120911AD, K31020120912AA, K31020120912AB, K31020120912AC, K31020120912AD, K31020120912AG, K31020120914AA, K31020120914AB, K31020120914AC, K31020120914AF, K31020120914AG, K31020120917AA, K31020120917AB, K31020120918AB, K31020120918AD, K31020120918AE, K31020120918AF, K31020120919AB, K31020120919AC, K31020120919AD, K31020120919AE, K31020120921AA, K31020120924AD, K31020120925AA, K31020120925AB, K31020120925AD, K31020120926AB, K31020120926AC, K31020120927AB, K31020121002AA, K31020121002AB, K31020121003AA, K31020121003AB, K31020121003AC, K31020121004AA, K31020121005AB, K31020121005AC, K31020121008AA, K31020121008AB, K31020121008AC, K31020121008AE, K31020121009AC, K31020121009AD, K31020121009AE, K31020121011AA, K31020121011AB, K31020121012AA, K31020121012AB, K31020121013AA, K31020121015AA, K31020121015AB, K31020121017AB, K31020121017AC, K31020121017AD, K31020121017AE, K31020121019AA, K31020121020AA, K31020121022AA, K31020121022AB, K31020121022AC, K31020121023AA, K31020121023AB, K31020121023AC, K31020121024AA, K31020121024AB, K31020121026AA, K31020121026AB, K31020121029AB, K31020121029AC, K31020121029AE, K31020121031AB, K31020121101AA, K31020121104AA, K31020121105AC, K31020121106AA, K31020121106AB, K31020121106AC, K31020121108AA, K31020121108AB, K31020121109AA, K31020121109AB, K31020121109AC, K31020121110AB, K31020121110AE, K31020121113AA, K31020121113AB, K31020121113AC, K31020121113AD, K31020121114AA, K31020121115AA, K31020121115AB, K31020121116AA, K31020121116AB, K31020121116AC, K31020121116AD, K31020121116AE, K31020121117AA, K31020121119AA, K31020121119AB, K31020121119AD, K31020121119AE, K31020121120AA, K31020121120AB, K31020121120AC, K31020121121AA, K31020121121AD, K31020121122AA, K31020121123AA, K31020121123AD, K31020121126AA, K31020121129AC, K31020121129AE, K31020121130AB, K31020121201AA, K31020121201AB, K31020121203AA, K31020121204AA, K31020121205AA, K31020121205AB, K31020121206AA, K31020121206AB, K31020121206AD, K31020121208AA, K31020121208AC, K31020121210AA, K31020121210AB, K31020121210AD, K31020121211AA, K31020121211AB, K31020121212AC, K31020121213AA, K31020121213AB, K31020121213AC, K31020121213AD, K31020121215AB, K31020121217AA, K31020121217AB, K31020121217AC, K31020121217AD, K31020121217AE, K31020121217AF, K31020121218AB, K31020121218AC, K31020121219AC, K31020121220AA, K31020121222AB, K31020121226AA, K31020121228AB, K31020121228AC, K31020121228AD, K31020121231AA, K31020130103AA, K31020130103AB, K31020130105AA, K31020130107AB, K31020130108AA, K31020130108AC, K31020130110AB, K31020130114AD, K31020130114AE, K31020130114AF, K31020130115AA, K31020130116AA, K31020130116AB, K31020130116AD, K31020130117AA, K31020130117AB, K31020130117AC, K31020130117AD, K31020130117AE, K31020130121AA, K31020130121AB, K31020130122AA, K31020130122AB, K31020130122AC, K31020130122AD, K31020130122AE, K31020130122AF, K31020130122AG, K31020130122AH, K31020130123AB, K31020130123AC, K31020130123AD, K31020130124AA, K31020130124AB, K31020130124AC, K31020130128AA, K31020130128AB, K31020130128AC, K31020130129AA, K31020130129AB, K31020130130AC, K31020130130AE, K31020130130AF, K31020130130AG, K31020130131AA, K31020130131AB, K31020130131AD, K31020130201AA, K31020130201AB, K31020130201AD, K31020130201AE, K31020130202AA, K31020130204AB, K31020130205AA, K31020130205AB, K31020130205AC, K31020130205AD, K31020130205AF, K31020130205AG, K31020130205AH, K31020130206AA, K31020130206AB, K31020130206AC, K31020130206AD, K31020130206AE, K31020130206AF, K31020130206AG, K31020130206AI, K31020130208AB, K31020130208AC, K31020130208AD, K31020130208AE, K31020130209AA, K31020130211AB, K31020130211AE, K31020130211AF, K31020130211AG, K3… (truncated, 52213 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

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Presence of particulate matter - Glass like particles.

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-0251-2026
Lot/product code:
Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.
Recalling firm:
Imprimis NJOF, LLC
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.

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-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.

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-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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 18, 2025

Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.

Potential for fraying on the body support strap.

ALL 50 STATES
Full report

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

Recall #:
98140
Lot/product code:
Model/Catalog Number: K660. ID Codes: K66020170425AA, K66020170612AA, K66020170621AA, K66020170622AA, K66020170626AA, K66020170626AB, K66020170626AC, K66020170627AC, K66020170627AD, K66020170628AA, K66020170629AA, K66020170703AA, K66020170705AA, K66020170711AA, K66020170712AA, K66020170712AC, K66020170713AB, K66020170716AA, K66020170717AA, K66020170717AB, K66020170804AA, K66020170805AA, K66020170807AA, K66020170810AA, K66020170810AB, K66020170811AA, K66020170811AC, K66020170815AA, K66020170817AC, K66020170818AC, K66020170831AA, K66020170831AB, K66020170906AA, K66020170906AB, K66020170911AA, K66020170911AB, K66020170911AC, K66020170913AA, K66020170914AA, K66020170915AA, K66020170921AA, K66020170923AA, K66020170926AA, K66020170927AA, K66020170928AA, K66020171004AA, K66020171006AA, K66020171006AB, K66020171007AA, K66020171010AA, K66020171010AB, K66020171019AA, K66020171020AA, K66020171024AA, K66020171026AA, K66020171026AB, K66020171026AC, K66020171028AA, K66020171030AA, K66020171101AA, K66020171101AB, K66020171103AC, K66020171107AA, K66020171107AB, K66020171116AA, K66020171121AA, K66020171127AA, K66020171128AA, K66020171128AB, K66020171206AA, K66020171207AA, K66020171214AA, K66020171216AA, K66020171219AA, K66020171227AA, K66020171227AC, K66020180102AA, K66020180104AA, K66020180109AA, K66020180109AB, K66020180113AA, K66020180113AB, K66020180117AA, K66020180118AA, K66020180120AA, K66020180124AA, K66020180126AA, K66020180130AA, K66020180130AB, K66020180131AA, K66020180131AC, K66020180203AA, K66020180206AA, K66020180206AB, K66020180208AB, K66020180209AA, K66020180213AA, K66020180216AA, K66020180220AA, K66020180220AB, K66020180220AC, K66020180221AA, K66020180226AA, K66020180227AA, K66020180227AB, K66020180306AA, K66020180309AA, K66020180312AA, K66020180322AA, K66020180326AB, K66020180403AA, K66020180405AA, K66020190306AA, K66020190306AB, K66020190322AA, K66020190325AA, K66020190325AB, K66020190401AA, K66020190401AB, K66020190401AC, K66020190402AA, K66020190406AA, K66020190406AB, K66020190408AA, K66020190408AB, K66020190410AA, K66020190415AA, K66020190416AA, K66020190416AB, K66020190417AA, K66020190418AA, K66020190418AB, K66020190418AC, K66020190422AA, K66020190423AA, K66020190424AA, K66020190429AA, K66020190501AA, K66020190501AB, K66020190501AC, K66020190501AD, K66020190501AE, K66020190502AA, K66020190508AA, K66020190508AB, K66020190509AA, K66020190514AA, K66020190520AB, K66020190520AD, K66020190521AB, K66020190522AA, K66020190523AB, K66020190527AA, K66020190528AA, K66020190528AB, K66020190528AC, K66020190604AA, K66020190605AA, K66020190606AB, K66020190611AA, K66020190612AA, K66020190614AA, K66020190617AB, K66020190617AC, K66020190618AA, K66020190618AB, K66020190618AC, K66020190620AA, K66020190624AA, K66020190624AB, K66020190625AA, K66020190702AA, K66020190705AA, K66020190705AB, K66020190708AA, K66020190709AA, K66020190709AB, K66020190710AA, K66020190710AB, K66020190716AA, K66020190717AA, K66020190722AB, K66020190722AC, K66020190724AB, K66020190726AA, K66020190730AA, K66020190731AA, K66020190801AA, K66020190806AA, K66020190806AB, K66020190806AC, K66020190812AA, K66020190814AA, K66020190815AA, K66020190815AB, K66020190819AA, K66020190820AA, K66020190822AA, K66020190822AB, K66020190822AC, K66020190824AA, K66020190830AA, K66020190831AA, K66020190904AA, K66020190906AA, K66020190913AA, K66020190916AA, K66020190919AA, K66020190919AB, K66020190919AC, K66020190926AA, K66020190930AD, K66020191001AA, K66020191001AB, K66020191003AA, K66020191003AC, K66020191003AD, K66020191005AA, K66020191005AB, K66020191005AC, K66020191007AA, K66020191008AA, K66020191009AA, K66020191015AA, K66020191016AA, K66020191017AA, K66020191018AA, K66020191022AA, K66020191025AB, K66020191025AC, K66020191025AD, K66020191029AA, K66020191030AB, K66020191114AA, K66020191119AA, K66020191121AA, K66020191122AA, K66020191126AA, K66020191126AB, K66020191128AA, K66020191205AA, K66020191206AA, K66020191206AC, K66020191207AA, K66020191210AA, K66020191217AA, K66020191217AB, K66020191220AA, K66020191224AA, K66020191224AB, K66020191227AA, K66020191228AA, K66020200103AA, K66020200103AB, K66020200107AA, K66020200116AA, K66020200116AB, K66020200120AA, K66020200120AB, K66020200121AA, K66020200121AB, K66020200122AA, K66020200127AA, K66020200127AB, K66020200127AC, K66020200129AA, K66020200129AB, K66020200129AC, K66020200131AA, K66020200204AA, K66020200205AA, K66020200207AA, K66020200210AA, K66020200210AB, K66020200211AA, K66020200212AA, K66020200212AB, K66020200213AA, K66020200214AA, K66020200215AA, K66020200217AA, K66020200217AB, K66020200220AA, K66020200227AA, K66020200229AA, K66020200302AA, K66020200302AB, K66020200303AA, K66020200304AA, K66020200304AB, K66020200309AA, K66020200309AB, K66020200310AA, K66020200312AA, K66020200320AC, K66020200320AD, K66020200325AA, K66020200326AA, K66020200328AA, K66020200403AA, K66020200428AA, K66020200430AA, K66020200505AA, K66020200505AB, K66020200505AC, K66020200505AD, K66020200508AA, K66020200514AA, K66020200520AA, K66020200521AA, K6… (truncated, 7685 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

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.

ALL 50 STATES
Full report

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 17, 2025

AlternatiV+ Max 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. 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

Fixone Biocomposite 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. 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

Genesis Dual Thread 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. 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

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 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

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)
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

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-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.

ALL 50 STATES
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.

ALL 50 STATES
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 16, 2025

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

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. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057
Recalling firm:
Vortex Surgical Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 16, 2025

Qunol, Extra Strength Turmeric Capsule, 1000mg ,HDPE bottle with cap, BIO7771 120 count bottle, BIO7772 120 count bottle ,BIO8281 60 count bottle .

Mold contamination detected for raw material lots that were produced in July and used in finished goods.

Full report

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

Recall #:
H-0418-2026
Lot/product code:
Part Number Lot 12811C120 BIO7771 12811C120BJ BIO7772 12811C60 BIO8281
Recalling firm:
QUTEN RESEARCH INSTITIUTE LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 16, 2025

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

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

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-0255-2026
Lot/product code:
Lot: 0522J23493, expires: 03/2027.
Recalling firm:
SpecGx, LLC
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.

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-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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

Xxx

ALL 50 STATES
Full report

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

Recall #:
98255
Lot/product code:
Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
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) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.

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 CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563; REF DYNJS2032F: UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051; REF DYNJ26209R: UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526; REF DYNJ26209S: UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383; REF DYNJ66285A: UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558; REF DYNJ66289B: UDI/DI 10193489950540 (EA)4019348… (truncated, 14933 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)