BIGNOPE
Ko-fi

Recalls affecting Puerto Rico

Data last updated: September 10, 2026 at 1:16 PM UTC

16,244 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
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, 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 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 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 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)
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

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 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

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

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 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

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.

ALL 50 STATES
Full report

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

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.

ALL 50 STATES
Full report

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)
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

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

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. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019
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)
UnclassifiedRisk not yet known
Medical deviceRecalled December 16, 2025

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

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:
UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
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 25GA I.D.D. Internal Delivery Device, VS0250.25

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 810123480456 Box UDI 810123480739 Lot 2410044
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) 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.

ALL 50 STATES
Full report

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 I2 Injection Kit, VS0500

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 810123480920 Box UDI 810123481330 Lot 2411012
Recalling firm:
Vortex Surgical Inc.
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 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

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)