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Recalls affecting North Carolina

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

17,306 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 March 2, 2026

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

ALL 50 STATES
Full report

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

Recall #:
98537
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

ALL 50 STATES
Full report

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

Recall #:
98540
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

ALL 50 STATES
Full report

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

Recall #:
98537
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 2, 2026

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.

Non-Sterility: microbial contamination identified as Paenibacillus phoenicis

ALL 50 STATES
Full report

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

Recall #:
D-0528-2026
Lot/product code:
Lot #: 25H065362; 25J013962; 25J034762; 25J064562; 25K004962; 25K041262; 25K065062; 25L015362; 25H065462; 25J014062; 25J035762; 25J064762; 25K005062; 25K041362; 25K065162; 25L015462; 25H066062; 25J014862; 25J035862; 25J064862; 25K006162; 25K041462; 25K065262; 25L015662; 25H066162; 25J014962; 25J035962; 25J064962; 25K006262; 25K041562; 25K065362; 25L016362; 25H066262; 25J033962; 25J050362; 25J065762; 25K006362; 25K041662; 25K064562; 25L015962; 25H066362; 25J034862; 25J050462; 25J066262; 25K005162; 25K040462; 25K064662; 25L016062; 25H066462; 25J034062; 25J050562; 25J066362; 25K006462; 25K040562; 25K065462; 25L030162; 25J013462; 25J034162; 25J050962; 25K004062; 25K019662; 25K040662; 25K065562; 25L058062; 25J013562; 25J034262; 25J051062; 25K004162; 25K020862; 25K040762; 25K065662; 25M022362; 25J014362; 25J034362; 25J051262; 25K005262; 25K020962; 25K040962; 25K066262; 25M028462; 25J014462; 25J034462; 25J051362; 25J065962; 25K019762; 25K041062; 25K066162; 25H065962; 25J034962; 25J051462; 25J065062; 25K019862; 25K041162; 25K064862; 25H065762; 25J035062; 25J051762; 25J065162; 25K021062; 25K041762; 25K065862; 25H065862; 25J035162; 25J051862; 25J066062; 25K021162; 25K041862; 25K079962; 25H066862; 25J035262; 25J051962; 25J066162; 25K021262; 25K041962; 25K080962; 25H066962; 25J035362; 25J075762;25K004262; 25K019962; 25K042162; 25K081062; 25J013162; 25J013662; 25J051162; 25K004362; 25K020062; 25K042262; 25K080062; 25J013262; 25J014562; 25J052062; 25K004462; 25K021362; 25K040862; 25K080162; 25J013362; 25J014662; 25J052162; 25K004562; 25K021462; 25K042062; 25K080262; 25J014162; 25J014762; 25J052262; 25K004662; 25K021562; 25K063862; 25K080362; 25J014262; 25J034562; 25J052362; 25K005362; 25K020162; 25K020562; 25K080462; 25H065562; 25J034662; 25J064362; 25K005462; 25K020262; 25K020362; 25K081162; 25H065662; 25J035462; 25J064462; 25K005562; 25K020662; 25K020462; 25K081262; 25H066562; 25J035562; 25J064662; 25K005662; 25K021662; 25K021962; 25K081362; 25H066662; 25J035662; 25J065262; 25K005762; 25K021762; 25K022062; 25K081462; 25H066762;25J050662; 25J065362; 25K004762; 25K021862; 25K063962; 25K081562; 25J012962; 25J050762; 25J065462; 25K004862; 25K040062; 25K064062; 25K080562; 25J013062; 25J050862; 25J065562; 25K005862; 25K040162; 25K064162; 25L014062; 25J013762; 25J051562; 25J065662; 25K005962; 25K040262; 25K064262; 25L014162; 25J013862; 25J051662; 25J065862; 25K006062; 25K040362; 25K064462; 25L015262 within Expiry
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 2, 2026

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

ALL 50 STATES
Full report

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

Recall #:
98540
Lot/product code:
All Model No.; All UDI; All Serial No.
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ41089 UDI-DI 10884389891360 Lot 21BBB592 DYNJ62827A UDI-DI 10193489306606 Lot 24BBN289 DYNJ47899A UDI-DI 10889942574681 Lots 21GBI377 21IBL299 21LBE099 21LBU529 22JBV803 DYNJ44123B UDI-DI 10195327381653 Lots 23FBR833 23GBN041 23HBW014 23JBO264 23JBW218 23KBI873 DYNJ68037A UDI-DI 10195327003630 Lots 21JBQ304 21LBQ205 22ABN185 22DBT349 22EBL611 22HBH550 22IBN880 22JBH689 22KBS987 22OBA368 23ABD642 23BBH830 23DBL865 23EBT367 23FBM946 23GBT261 DYNJ0101291F UDI-DI 10195327286644 Lots 22KDB751 23EDA119 23EDB388 23FDA396 23GDA313 23HDA759 23LDB909 24ADB667 24GDA294 24HDB515
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

ALL 50 STATES
Full report

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

Recall #:
98422
Lot/product code:
Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

ALL 50 STATES
Full report

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

Recall #:
98422
Lot/product code:
Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF220005, MDUF220005, MDUF220437, MDUF220437, MDUF220446, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008, MDUF220009, MDUF220010, MDUF220011, MDUF220012, MDUF220013, MDUF220014, MDUF220015, MDUF220016, MDUF220017, MDUF220018, MDUF220019, MDUF220020, MDUF220021, MDUF220022, MDUF220023, MDUF220024, MDUF220025, MDUF220026, MDUF220027, MDUF220028, MDUF220029, MDUF220030, MDUF220031, MDUF220032, MDUF220033, MDUF220034, MDUF220035, MDUF220036, MDUF220037, MDUF220038, MDUF220039, MDUF220040, MDUF220042, MDUF220043, MDUF220044, MDUF220045, MDUF220046, MDUF220047, MDUF220048, MDUF220049, MDUF220050, MDUF220051, MDUF220052, MDUF220053, MDUF220054, MDUF220055, MDUF220056, MDUF220057, MDUF220058, MDUF220060, MDUF220061, MDUF220062, MDUF220063, MDUF220064, MDUF220065, MDUF220066, MDUF220067, MDUF220069, MDUF220070, MDUF220071, MDUF220072, MDUF220074, MDUF220075, MDUF220076, MDUF220077, MDUF220078, MDUF220079, MDUF220080, MDUF220081, MDUF220082, MDUF220083, MDUF220084, MDUF220085, MDUF220086, MDUF220087, MDUF220088, MDUF220089, MDUF220090, MDUF220091, MDUF220092, MDUF220093, MDUF220094, MDUF220095, MDUF220096, MDUF220097, MDUF220098, MDUF220100, MDUF220101, MDUF220102, MDUF220103, MDUF220106, MDUF220109, MDUF220110, MDUF220111, MDUF220113, MDUF220114, MDUF220115, MDUF220116, MDUF220117, MDUF220119, MDUF220120, MDUF220123, MDUF220124, MDUF220126, MDUF220127, MDUF220128, MDUF220130, MDUF220131, MDUF220133, MDUF220135, MDUF220137, MDUF220138, MDUF220139, MDUF220140, MDUF220141, MDUF220142, MDUF220143, MDUF220144, MDUF220145, MDUF220146, MDUF220147, MDUF220149, MDUF220150, MDUF220151, MDUF220152, MDUF220153, MDUF220154, MDUF220155, MDUF220156, MDUF220157, MDUF220158, MDUF220159, MDUF220160, MDUF220161, MDUF220162, MDUF220163, MDUF220164, MDUF220165, MDUF220166, MDUF220167, MDUF220168, MDUF220170, MDUF220171, MDUF220172, MDUF220173, MDUF220174, MDUF220175, MDUF220176, MDUF220177, MDUF220178, MDUF220179, MDUF220180, MDUF220181, MDUF220182, MDUF220183, MDUF220184, MDUF220185, MDUF220186, MDUF220187, MDUF220188, MDUF220189, MDUF220190, MDUF220191, MDUF220192, MDUF220193, MDUF220194, MDUF220195, MDUF220196, MDUF220198, MDUF220199, MDUF220200, MDUF220201, MDUF220202, MDUF220203, MDUF220204, MDUF220205, MDUF220206, MDUF220207, MDUF220208, MDUF220209, MDUF220210, MDUF220211, MDUF220212, MDUF220213, MDUF220214, MDUF220216, MDUF220217, MDUF220218, MDUF220219, MDUF220220, MDUF220221, MDUF220222, MDUF220223, MDUF220224, MDUF220225, MDUF220226, MDUF220227, MDUF220228, MDUF220229, MDUF220230, MDUF220231, MDUF220232, MDUF220233, MDUF220234, MDUF220235, MDUF220237, MDUF220238, MDUF220240, MDUF220241, MDUF220242, MDUF220243, MDUF220244, MDUF220245, MDUF220246, MDUF220247, MDUF220248, MDUF220249, MDUF220250, MDUF220251, MDUF220252, MDUF220253, MDUF220254, MDUF220255, MDUF220256, MDUF220257, MDUF220258, MDUF220259, MDUF220260, MDUF220261, MDUF220262, MDUF220263, MDUF220264, MDUF220265, MDUF220266, MDUF220267, MDUF220268, MDUF220269, MDUF220270, MDUF220271, MDUF220272, MDUF220273, MDUF220274, MDUF220275, MDUF220276, MDUF220277, MDUF220278, MDUF220279, MDUF220280, MDUF220281, MDUF220283, MDUF220284, MDUF220285, MDUF220286, MDUF220287, MDUF220288, MDUF220289, MDUF220291, MDUF220292, MDUF220294, MDUF220295, MDUF220296, MDUF220297, MDUF220298, MDUF220299, MDUF220300, MDUF220301, MDUF220302, MDUF220303, MDUF220304, MDUF220305, MDUF220306, MDUF220307, MDUF220308, MDUF220309, MDUF220310, MDUF220311, MDUF220312, MDUF220313, MDUF220314, MDUF220315, MDUF220316, MDUF220317, MDUF220318, MDUF220320, MDUF220321, MDUF220322, MDUF220323, MDUF220324, MDUF220326, MDUF220327, MDUF220328, MDUF220329, MDUF220330, MDUF220332, MDUF220333, MDUF220334, MDUF220335, MDUF220336, MDUF220337, MDUF220338, MDUF220339, MDUF220340, MDUF220341, MDUF220342, MDUF220343, MDUF220344, MDUF220345, MDUF220346, MDUF220347, MDUF220348, MDUF220349, MDUF220350, MDUF220351, MDUF220358, MDUF220359, MDUF220360, MDUF220361, MDUF220362, MDUF220364, MDUF220365, MDUF220366, MDUF220367, MDUF220368, MDUF220370, MDUF220371, MDUF220373, MDUF220374, MDUF220375, MDUF220377, MDUF220378, MDUF220379, MDUF220380, MDUF220381, MDUF220382, MDUF220383, MDUF220384, MDUF220385, MDUF220388, MDUF220389, MDUF220391, MDUF220392, MDUF220394, MDUF220397, MDUF220399, MDUF220400, MDUF220402, MDUF220403, MDUF220404, MDUF220405, MDUF220406, MDUF220407, MDUF220408, MDUF220409, MDUF220410, MDUF220415, MDUF220416, MDUF220417, MDUF220418, MDUF220419, MDUF220420, MDUF220421, MDUF220423, MDUF220424, MDUF220425, MDUF220426, MDUF220428, MDUF220429, MDUF220431, MDUF220432, MDUF220433, MDUF220434, MDUF220435, MDUF220436, MDUF220438, MDUF220439, MDUF220440, MDUF220441, MDUF220442, MDUF220443, MDUF220444, MDUF220445, MDUF220448, MDUF220449, MDUF220450, MDUF220457, MDUF220458, MDUF220459, MDUF220460, MDUF220461, MDUF220462, MDUF220463, M… (truncated, 11118 characters total — see the official FDA record for the full value)
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353 PHS463660F UDI-DI 10195327096991 Lots 22BBT652 22DBK236 DYNJ43580C UDI-DI 10889942249398 Lots 21BDB710 21DDB799 DYNDA2213A UDI-DI 10889942925421 Lots 23LBC294 DYNJ65277A UDI-DI 10193489409536 Lots 24BBD609 24BBD609A DYNJ0842793F UDI-DI 10193489345230 Lots 21CDA191 21CDC092 21EDA769 21GDB289 21HDC822 22BDB295 22DDA792 22EDB725 22IDC164 DYNJ67918 UDI-DI 10193489459081 Lots 21ABP630 21DBL459 21EBD905 21HBE280 21HBE285 21IBS959 21VBD188 DYNJ56666B UDI-DI 10888277740273 Lots 21BMB700 21CMA789 DYNJ44123A UDI-DI 10889942952977 Lots 21ABV982 21CBB916 21HBQ740 21KBE936 21VBC816 22ABS461 22CBX354 22DBD608 22EBT322 22GBR526 22HBS119 22LBA937 22LBM278 23ABJ758 23BBG292 23CBD680 DYNJ51126B UDI-DI 10195327044138 Lots 22ADA961 22BDC241 22DDA320 22DDB652 22FBD047 22FBH293 22HBQ223 22HBY535 22JBG518 PAIN1454 UDI-DI 10193489688863 Lots 21CBA985 21DBU969 21FBN495 21GBG636 21KBJ919 22ABJ583 22BBN243 22IBT753 22KBA570 23ABK226 23IBE552 23JBF419 23KBJ152 DYNJ905160I UDI-DI 10193489397482 Lots 21BBE987 21DBD058 21EBC916 DYNJ0843063J UDI-DI 10193489345377 Lots 21CDA233 21EDC220 21GDC682 21IDA570 21JDA064 21LDA151 22ADC136 22CDB166 22EDA616 22FDB836 22HDB150 22KDA481 DYNJ37304F UDI-DI 10889942727919 Lot 23KMI510 DYNJ56386B UDI-DI 10888277762886 Lots 21CBX170 21GBQ837 21JBW253 21LBH797 22ABX259 22BBC246 22CBW026 22DBU970 22GBA195 22HBL094 22LBH829 23ABG503 23ABO274 23BBO056 23DBQ675 23FBQ670 23HBV115 23JBC749 23JBP144 DYNJ907758 UDI-DI 10193489872002 Lot 21FBF623 DYNJ40952 UDI-DI 10884389898826 Lot 21FBK360 DYNJ60715 UDI-DI 10193489520279 Lot 24ABO126 DYNJ37484B UDI-DI 10889942777792 Lots 21BDA459 21DDA549 21DDB648 21GDC975 21IDB972 21JDC475 21LDB205 22ADC256 22BDB581 22FDA100 22GDB220 22IDB953 22KDB836 23ADA661 23CDB420 23DDC200 DYNJ908706A UDI-DI 10195327406042 Lots 23FMI173 23GMB991 23HMF410 23IMF032 DYNJ0101339J UDI-DI 10193489472516 Lots 21BDA985 21DDB919 21GDD035 21HDC817 21KDA162 22ADA293 22BDB849 22EDB044 22HDB148 22IDC162 DYNJ69090 UDI-DI 10193489883596 Lots 21FMF068 22EMB610 DYNJ56260B UDI-DI 10193489569827 Lots 24ABR394
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
Full report

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

Recall #:
98598
Lot/product code:
1. Medline SKU 70083007, UDI/DI each 10193489065855, UDI/DI case 30193489065859, Lot Numbers: 0000077029, 0000081537, 0000084335, 0000087347, 0000089563, 0000113792, 0000115753, 0000122956, 0000127785, 0000131986, 0000158748, 0000175535, 0000187926; 2. Medline SKU 70084007, UDI/DI each 10193489065893, UDI/DI case 30193489065897, Lot numbers: 0000078186, 0000081539, 0000084274, 0000086756, 0000089554, 0000094842, 0000096918, 0000105613, 0000109479, 0000111244, 0000114562, 0000115421, 0000117317, 0000118251, 0000120265, 0000120769, 0000121714, 0000123466, 0000124589, 0000131984, 0000131989, 0000138071, 0000140322, 0000142850, 0000147002, 0000152069, 0000162694, 0000173507, 0000174662, 0000174773, 0000176555, 0000178806, 0000189895; 3. Medline SKU 70084017, UDI/DI each 10193489065916, UDI/DI case 20193489065913, Lot Numbers: 0000084509, 0000086823, 0000095687, 0000165551, 0000165868, 0000166300; 4. Medline SKU 80083007, UDI/DI each 10193489066753, UDI/DI case 30193489066757, Lot Numbers: 0000097388, 0000127072, 0000135012, 0000137004; 5. Medline SKU 80084007, UDI/DI each 10193489066791, UDI/DI case 30193489066795, Lot Numbers: 0000080553, 0000080919, 0000082969, 0000085041, 0000088044, 0000094514, 0000099870, 0000101882, 0000102372, 0000105155, 0000107328, 0000109442, 0000112810, 0000112966, 0000114317, 0000115744, 0000117572, 0000118722, 0000118962, 0000119950, 0000120931, 0000121305, 0000121393, 0000122583, 0000122606, 0000123102, 0000126198, 0000126566, 0000127132, 0000130798, 0000131678, 0000132838, 0000137176, 0000139543, 0000140507, 0000142057, 0000142279, 0000143110, 0000143264, 0000143714, 0000148872, 0000150059, 0000150488, 0000151054, 0000151295, 0000151300, 0000151768, 0000152754, 0000153438, 0000154148, 0000156028, 0000158045, 0000158122, 0000159113, 0000159652, 0000160479, 0000160753, 0000161269, 0000162083, 0000162090, 0000162336, 0000162895, 0000164540, 0000164541, 0000166504, 0000166983, 0000167995, 0000168000, 0000169147, 0000169560, 0000169793, 0000170823, 0000171778, 0000173402, 0000174087, 0000174697, 0000174747, 0000176011, 0000176240, 0000176850, 0000177923, 0000179193, 0000179414, 0000180511, 0000182186, 0000182779, 0000182782, 0000185643, 0000186234, 0000186874, 0000187362, 0000187363, 0000188837, 0000188842, 0000188845; 6. Medline SKU 80084017, UDI/DI each 10193489066814, UDI/DI case 20193489066811, Lot Numbers: 0000101535, 0000103862, 0000105095, 0000106954, 0000108237, 0000122887, 0000126590, 0000127159, 0000128360, 0000128852, 0000132717, 0000134047, 0000135616, 0000140813, 0000144899, 0000148530, 0000149322, 0000152430, 0000161279, 0000164538, 0000169107, 0000173193, 0000173256, 0000182141, 0000183619, 0000187345, 0000188399.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

SIGNA Premier systems

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

ALL 50 STATES
Full report

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

Recall #:
98579
Lot/product code:
UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677
Recalling firm:
GE Healthcare LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ66746 UDI-DI 10193489375527 Lot 24BBD114 DYNJ85702 UDI-DI 10195327536213 Lot 24ABP053
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; DYNJ41941D lots 24LBU189 25EBO278; DYNJ42094B lots 21DDA142 21EDA157 21FDA721 21HDC553 21JDB308 21KDC411 22ADB304 22DDA696 22EDB388 22GDB457 22HDC130 22KDB833 23ADA446 23BDB104 23DDA367 23EDA799 23FDB379 23HDB674 23KDA291 23KDC457 24ADA586 25DMB689 25EMH157; DYNJ42136B lots 20XBH732 21FBD068 21FBP137 21GBM895 21IBO938 21JBW334 21LBK626 22DBB070 22DBT749 22DBT751 22GBL802 22KMB909 23AMA925 23AMA926 23DMC128 23EMK206 23FMD274 23GMI199 23IMF729 23KMG485 25DMG003 25EMJ002; DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296; DYNJ55359B lots 21CBY049 21HBJ347 21KBK603 21LBU329 22BBN805 22DBG945 22DBG946 22EBI619 22EBI620 22GBV248 22IBD917 22JBP712 22KBO285 22LBF294 23BBN404 23CBU106; DYNJ61006 lots 21BBM590 21DBE579 25EBA174; DYNJ62745 lots 21CBZ899 21EBI827 21HBB755 21KBR329 21LBP817 22BBB761 22BBY454 22FBG531 22FBG532 22GBH888 22HBH100 22JBS334 23ABF660 23BBR901 23DBC087 23EBN460 23FBQ453 23GBH068 23IBB014 23JBP276 23LBJ141 24BBR785 24BBS830; VASC1109 lots 25BBR047
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

ALL 50 STATES
Full report

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

Recall #:
98534
Lot/product code:
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
Recalling firm:
Cardinal Health 200, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ0101278F UDI-DI 10193489352351 (EA) 40193489352352 (CS) LOTS 22CDB133 22EDA975 22FDA831 22HDC403 DYNJ0101278G UDI-DI 10195327286477 (EA) 40195327286478 (CS) LOTS 22KDB109 22LDA476 23CDA805 23DDB546 23EDC278 23FDC023 23JDA625 23KDB893 24ADB642 24BDB842 24CDB908 24GDA043 24IDA026 DYNJ0101278I UDI-DI 10198459119477 (EA) 40198459119478 (CS) LOT 24JDC169 DYNJ56262 UDI-DI 10889942624331 (EA) 40889942624332 (CS) LOT 24ABO125 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ0101278F lots 21ADC024 21CDA355 21EDA527 21GDC529 21IDA040 21IDA786 21JDB214 21KDC443 22ADC117 22GDA789; DYNJ0101278G lots 23HDC100; DYNJ0101278I lots 25AME306 25AMI354 25BMG147 25BMG147A
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ85723 UDI-DI 10195327538491 Lot 24ABO130
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333 (EA) 40195327397334 (CS) LOTS 23DBP804 23FBH420 23GBF219 23HBJ487 23IBO358 23KBA337 23LBC194 24ABI270 24CMD265 24CMG190 24EMJ851 24GMK004 24HMF977 24JMC975 24KMH243 24LMG715 DYNJ37724K UDI-DI 10195327531256 (EA) 40195327531257 (CS) LOTS 23JBS842 23LMF451 24BMH462 24EMI397 24EMJ503 24GMK100 24HMH553 24JMA589 24KMJ234 DYNJ38395G UDI-DI 10195327286767 (EA) 40195327286768 (CS) LOTS 22LMF926 23BMA411 23DMD076 23DMG120 DYNJ44293F UDI-DI 10195327265182 (EA) 40195327265183 (CS) LOTS 23CBH106 DYNJ44293G UDI-DI 10195327427276 (EA) 40195327427277 (CS) LOTS 23HBI186 23HBX788 23IBP108 23JBQ388 23JBT471 23KBX452 23LBU382 24ABH531 24ABU590 24CBQ251 24FBS495 24HBB684 DYNJ44293J UDI-DI 10198459252471 (EA) 40198459252472 (CS) LOTS 25ABS436 25CBC411 25DBS739 25EBN111 25GBK945 DYNJ47665F UDI-DI 10195327355210 (EA) 40195327355211 (CS) LOTS 23GMI750 23IMG679 DYNJ47665G UDI-DI 10195327535810 (EA) 40195327535811 (CS) LOTS 23KMC220 23LMD957 24AMH318 24CMC513 24CMF048 24EMF765 24FMB398 24GMD088 24HMG619 24KMC285 DYNJ51126C UDI-DI 10195327299996 (EA) 40195327299997 (CS) LOTS 24EBL991 24GBL127 24HBB815 24IBI837 24KBT622 DYNJ51239C UDI-DI 10195327663728 (EA) 40195327663729 (CS) LOTS 24FBM878 DYNJ51697C UDI-DI 10195327517267 (EA) 40195327517268 (CS) LOTS 24HBJ453 24JBQ619 24KBL433 DYNJ55359C UDI-DI 10198459167447 (EA) 40198459167448 (CS) LOTS 24JBW626 24LBJ492 25ABM557 DYNJ55359D UDI-DI 10198459253584 (EA) 40198459253585 (CS) LOTS 25CBJ836 25EBB180 25FBC620 DYNJ56666D UDI-DI 10195327366780 (EA) 40195327366781 (CS) LOTS 23FMB079 23HMC084 23JMH176 DYNJ57723C UDI-DI 10195327533007 (EA) 40195327533008 (CS) LOT 24GMA688 DYNJ62595C UDI-DI 10195327386511 (EA) 40195327386512 (CS) LOTS 23FBD527 23FBK131 DYNJ62595D UDI-DI 10195327482626 (EA) 40195327482627 (CS) LOTS 23IBD384 23JBT585 23KBV027 23LBS746 24ABX161 24BBA663 24DBO214 24EBN761 24GBJ844 24IBT077 24JBX775 24KBR861 DYNJ62858C UDI-DI 10195327265212 (EA) 40195327265213 (CS) LOTS 23GMB070 24BMD149 24HMA369 24HMJ618 24JME908 DYNJ63434D UDI-DI 10195327611200 (EA) 40195327611201 (CS) LOTS 24BBU728 24CBK568 24FBE982 24GBP703 24HBS440 24JBD723 24JBN341 24LBQ810 DYNJ65162B UDI-DI 10195327443948 (EA) 40195327443949 (CS) LOTS 23KBA866 23LBL832 DYNJ66366D UDI-DI 10195327493387 (EA) 40195327493388 (CS) LOTS 23LMC414 24BMD428 24EMG916 24EMJ523 24GMC227 24GMG298 24GMI398 DYNJ66366F UDI-DI 10198459033117 (EA) 40198459033118 (CS) LOTS 24HMI310 24IMB847 24IMD381 DYNJ66631A UDI-DI 10195327225193 (EA) 40195327225194 (CS) LOTS 23ABB849 23ABP692 23BBP518 23HBN017 23IBO135 24BBU796 24EBA783 24GBD375 24HBG027 24IBG782 24JBU401 24KBH848 24LBE218 DYNJ68653B UDI-DI 10195327475970 (EA) 40195327475971 (CS) LOTS 23IBO333 23JBE362 23KBS420 DYNJ68653C UDI-DI 10195327626570 (EA) 40195327626571 (CS) LOTS 24BBU897 24EBB962 24EBJ449 … (truncated, 15819 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 February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248 23EBK921 23FBS130 23HBB516 23IBS065 23JBP123 23LBP196 24ABR004 24ABR121 24BBG855 24GBV377 24JBI914 24KBD153 24LBB665 DYNJ35615G UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT 23EBR748 DYNJ0842516G UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS 24CDB991 24GDB891 24IDA796 24KDB683 DYNJ61926 UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS 23CBK311 23DBM226 23FBP893 23GBN159 23HBC859 23JBH552 23LBV456 24DBM081 24EBS504 24FBR479 DYNJ47645C UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS 23IMH312 23LMD467 24BMB620 24DMD512 24FMF757 24GMD538 24JMC369 24KMB831 24LMD945 DYNJ47782G UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT 24GMA622 DYNJT2201S UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT 23HMG629 DYNJ33415A UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT 24CBG963 DYNJ64877B UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS 23CBF259 23HBM117 23HBO973 23KBD360 23LBG859 24ABB266 24CMJ034 24FMD963 24HMH185 24JMD105 DYNJ65925D UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT 24DLA029 DYNJ44100M UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS 23IMG347 23JMI669 23LME170 24AMI085 24CMA877 24CMJ446 24DME309 24FMC387 24FMC900 24FMF012 24FMH007 24GMC363 24HMF632 24JMF664 24LMD487 DYNJ0516014AG UDI-DI 10195327271640 (EA) 40195327271641 (CS) LOTS 23BME190 23DMH005 23KMH805 23KMI253 23LMH275 24AMH347 24CMI868 24DMI402 24DMK427 24EMG633 24IMB650 24IMJ127 24KMC298 DYNJ41556F UDI-DI 10193489968170 (EA) 40193489968171 (CS) LOTS 23IME423 23IMH983 DYNJ68365D UDI-DI 10195327525040 (EA) 40195327525041 (CS) LOT 23JBH517 DYNJ907758D UDI-DI 10195327351335 (EA) 40195327351336 (CS) LOTS 23FBP055 23HBC362 23HBL227 23HBX060 23KBB106 24CBT278 24CBV291 24HBE808 24HBR182 DYNJ907758F UDI-DI 10198459128622 (EA) 40198459128623 (CS) LOTS 24JBM379 24KBC281 DYNJ907960C UDI-DI 10195327347451 (EA) 40195327347452 (CS) LOT 24CBT833 DYNJ42557B UDI-DI 10889942135806 (EA) 40889942135807 (CS) LOT 24BBA461 DYNJ61411 UDI-DI 10193489562705 (EA) 40193489562706 (CS) LOT 23GBH973 DYNJ61411A UDI-DI 10195327483234 (EA) 40195327483235 (CS) LOTS 23IBH456 23JBN809 DYNJ61411B UDI-DI 10195327628697 (EA) 40195327628698 (CS) LOTS 24DBE155 24LBE209 DYNJ80160 UDI-DI 10195327013226 (EA) 40195327013227 (CS) LOT 24CBJ103 DYNJ40952B UDI-DI 10195327203726 (EA) 40195327203727 (CS) LOTS 24EBT279 24GBQ711 24HBR555 24JBO326 24LBM313 DYNJ61383B UDI-DI 10193489751277 (EA) 40193489751278 (CS) LOTS 23FLA104 23HLA490 23ILB095 23KBP994 23LBD911 24ALA301 DYNJ54762D UDI-DI 10195327031725 (EA) 40195327031726 (CS) LOT 24ABX637 DYNJ55338B UDI-DI 10193489859027 (EA) 40193489859028 (CS) LOT 22GMG972 DYNJ69246A UDI-DI 10198459178931 (EA) 40198459178932 (CS) LOTS 24LBA791 25ABA813 25CBF356 25DBA846 DYNJ52606F UDI-DI 10193489343298 (EA) 40193489343299 (CS) LOTS 23ELB102 23GLA496 23HLB190 23JLA642 23JLB201 24BLA295 24DLA690 24FLA227 24GLA493 24HLA557 24ILA766 24KLA315 DYNJ49802C UDI-DI 10193489461602 (EA) 40193489461603 (CS) LOT 24BBD110 DYNJ57512 UDI-DI 10889942748273 (EA) 40889942748274 (CS) LOT 24ABS819 DYNJ58063 10889942816675 40889942816676 24ABM343 DYNJ84953 10195327440299 40195327440290 24FBM720 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** DYNJ0516014AG Lots 22LMD393 23DMG745 23HMB539 23LMH275A; DYNJ0842516G Lots 22KDA699 22LDC077 23DDB550 23GDA061 23HDC455 23JDA626 23LDB990 25BMH951 25BMI475; DYNJ26783D Lots 21CBL983 21FBE677 21GBR689 21JBA358 21KBF796 21LBG769 22ABX397 22CBA514 22FBK918 22GBO115 22JBU884 22KBJ430 23ABN303 23BBN053 25ABH287 25ABV765 25BBE142 25CBE875; DYNJ40952B Lots 22HBH043 22JBJ979 23DBR448 23FBE598 23JBL097 23KBH476 24ABR924 25BBS344 DYNJ44100M Lots 23AMJ315 23CMH807 23EMG216 23EMG763 23GMH722 23HMF163 23LMC066 25BMB884 25CMC633 25EMG169; DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532; DYNJ52606F Lots 21AKA467 21DKA121 21GLA734 21HLA612 21ILA348 21JLA304 21LLA164 22ALA074 22ALA885 22BLA931 22DLA955 22FLA562 22HLA294 22ILB142 22JLA807 23BLA662 23CLA943 25ALA106 25CLA447; DYNJ61383B Lots 21CLA367 21FLA054 21GLA195 21JLA060 21LLA062 22CLA063 22CLA337 22DLA685 22DLB071 22ELB118 22JLA236 22KLA964 23ALA936 23CLA512 23ELA390 23FLA461 23GLA377 23JLB155 23KLA301 23KLA89… (truncated, 5621 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 February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ38587A UDI-DI 10193489754070 (EA) 40193489754071 (CS) LOTS 20BBF696 20EBH917 20FBW435 20HBM667 20JBF107 20KBW292 20LBS930 21EBB195 21FBR610 21GBS936 21GBS940 21JBU912 21KBP999 22ABX182 22EBI922 22GBZ788 22JBL031 23BBN160 DYNJ38587B UDI-DI 10195327397326 (EA) 40195327397327 (CS) LOTS 23DBP789 23FBM124 23HBW639 23JBN841 24ABG236 24CBM867 24FME120 24JMD066 24LME187 DYNJ30078D UDI-DI 10889942138647 (EA) 40889942138648 (CS) LOTS 23CBK546 23FBQ481 23IBQ435 23JBR634 23LBG856 24ABE287 24BBS264 24EBQ336 24GBJ987 24JBO830 DYNJ59108B UDI-DI 10198459138461 (EA) 40198459138462 (CS) LOT 24JBP861 ***Updated 5/20/26 - The following lots were included in the customer communication but not in the FDA submission.*** DYNJ30078D Lots 21EBD861 21IBM130 21IBV938 21IBV939 21IBV940 21LBB809 22ABZ810 22BBV614 22FBL865 22IBE477 22JBH508 22KBJ437 22OBC310 23BBT881 23EBK298; DYNJ38587B Lots 25BMB873; DYNJ59108B Lots 24LBT539
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ0842873L LEFT HEART DYNJ45984J LIPO PACK DYNJ87218 MAA Y90 TRAY DYNJ82191D MAIN OR CATH LAB DYNJ61373B MINIMALLY INVASIVE PACK-LF DYNJ0843063M NEURO CERVICAL PACK DYNJ0101287M NEURO RADIOLOGY RICHMOND DYNJ68365F NEURO VP SHUNT PACK-LF DYNJ0843121L NON-VASCULAR PACK DYNJ56386C, DYNJ56386D OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B OR RADIOLOGY PACK DYNJ62747A PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C PICC ABSCESS PACK-LF DYNJ0774005I PICC TRAY DYNJ30554I PODIATRY PACK DYNJ46333G POSTERIOR SPINE PACK-LF DYNJ0843339P RRMC ANGIO PACK DYNJ36338D SPECIAL PROCEDURE PACK DYNJ88258 VASCULAR ACCESS PACK-LF DYNJ0101291G VASCULAR HYBRID DYNJ57543K VASCULAR PACK DYNJ82220D VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M WPH EP PACK DYNJ62745A

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ0429339L UDI-DI 10195327586508 (EA) 40195327586509 (CS) LOTS 24BMG223 24DMG627 DYNJ0429339M UDI-DI 10198459021541 (EA) 40198459021542 (CS) LOTS 24GMH043 24HMK218 DYNJ0774026K UDI-DI 10198459053115 (EA) 40198459053116 (CS) LOTS 24FBR752 24GBE275 24HBJ727 24IBD206 24KBB390 24KBT291 DYNJ83746B UDI-DI 10198459077760 (EA) 40198459077761 (CS) LOTS 24HBB576 24JBF419 24LBG659 DYNJ85557A UDI-DI 10195327657901 (EA) 40195327657902 (CS) LOT 24HBT042 DYNJ17218S UDI-DI 10195327617547 (EA) 40195327617548 (CS) LOTS 24ADC205 24DDA061 DYNJ17218T UDI-DI 10198459014956 (EA) 40198459014957 (CS) LOTS 24FDA217 24GDB466 24IDB458 DYNJ0842499L UDI-DI 10198459119248 (EA) 40198459119249 (CS) LOT 24LDB079 DYNJ0842478M UDI-DI 10198459119255 (EA) 40198459119256 (CS) LOT 24LDB078 DYNJ21259O UDI-DI 10195327666323 (EA) 40195327666324 (CS) LOTS 24EBQ265 24EBQ331 24KBG416 24LBP987 DYNJ68653D UDI-DI 10198459123122 (EA) 40198459123123 (CS) LOTS 24IBI799 24JBJ553 24KBT807 24LBQ652 DYNJ50779G UDI-DI 10195327686499 (EA) 40195327686490 (CS) LOTS 24GMA788 24HMA312 24IMI472 24KMC197 DYNJ51423G UDI-DI 10198459022395 (EA) 40198459022396 (CS) LOTS 24FLA167 24HLA548 24HLA720 24JLA538 DYNJ0101292I UDI-DI 10198459119064 (EA) 40198459119065 (CS) LOTS 24JDA749 24KDB872 24LDA883 DYNJ0842793I UDI-DI 10198459119095 (EA) 40198459119096 (CS) LOTS 24IDA565 24JDB658 DYNJ87263 UDI-DI 10198459026263 (EA) 40198459026264 (CS) LOTS 24GMF532 24KME090 DYNJ0842873L UDI-DI 10198459119163 (EA) 40198459119164 (CS) LOTS 24JDB216 24KMI624 DYNJ45984J UDI-DI 10198459072499 (EA) 40198459072490 (CS) LOTS 24HMD351 24IMJ054 DYNJ87218 UDI-DI 10198459018800 (EA) 40198459018801 (CS) LOTS 24GBA517 24IBO012 24LBT366 DYNJ82191D UDI-DI 10198459099755 (EA) 40198459099756 (CS) LOTS 24HMI555 24IMF587 24KMD232 DYNJ61373B UDI-DI 10195327591298 (EA) 40195327591299 (CS) LOTS 23LBS736 24ABA334 24KBF375 24LBM612 DYNJ0843063M UDI-DI 10198459119460 (EA) 40198459119461 (CS) LOTS 24LDB299 DYNJ0101287M UDI-DI 10198459119491 (EA) 40198459119492 (CS) LOTS 24JDA631 24KDB258 DYNJ68365F UDI-DI 10198459130038 (EA) 40198459130039 (CS) LOTS 24LBA409 24LBJ115 24LBJ634 DYNJ0843121L UDI-DI 10198459119507 (EA) 40198459119508 (CS) LOTS 24JMB397 24JMF145 DYNJ56386C UDI-DI 10195327571252 (EA) 40195327571253 (CS) LOTS 23LBI856 24CBJ902 24FBG624 24FBI743 24FBO911 24HBM314 DYNJ56386D UDI-DI 10198459123382 (EA) 40198459123383 (CS) LOTS 24JBX744 24KBH891 24LBS655 DYNJ83656A UDI-DI 10195327600006 (EA) 40195327600007 (CS) LOTS 24DMF381 24GMG344 DYNJ83656B UDI-DI 10198459119538 (EA) 40198459119539 (CS) LOT 24KMF093 DYNJ62747A UDI-DI 10195327576530 (EA) 40195327576531 (CS) LOTS 24EBI547 24FBR560 24IBG783 24LBK728 DYNJ30551J UDI-DI 10198459131004 (EA) 40198459131005 (CS) LOTS 24LLA323 25HLA222 DYNJ61383C UDI-DI 10195327593346 (EA) 40195327593347 (CS) LOTS 24CLA801 24DLA314 24ELA254 24FLA499 24GLA460 24HLA582 24HLB160 24JLB130 24KLB068 24LLA374 25ALA225 25ALB027 25CLA749 25DLA276 25GLA032 25ILA468 25JLA750 DYNJ0774005I UDI-DI 10198459053184 (EA) 40198459053185 (CS) LOTS 24GBE276 24HBS310 DYNJ30554I UDI-DI 10198459131011 (EA) 40198459131012 (CS) LOTS 24LLB049 25HLA223 25HLA971 DYNJ46333G UDI-DI 10195327542320 (EA) 40195327542321 (CS) LOT 24ABS351 DYNJ0843339P UDI-DI 10198459119330 (EA) 40198459119331 (CS) LOTS 24JDC273 24LDA042 DYNJ36338D UDI-DI 10195327624002 (EA) 40195327624003 (CS) LOTS 24BMJ645 24CMG670 24DMC608 24EMH999 24FME392 24JMD753 24JMI596 24KME048 24LMA450 DYNJ88258 UDI-DI 10198459133114 (EA) 40198459133115 (CS) LOT 24JBB074 DYNJ0101291G UDI-DI 10198459119439 (EA) 40198459119430 (CS) LOTS 24IDB422 24KDB372 DYNJ57543K UDI-DI 10198459004124 (EA) 40198459004125 (CS) LOTS 24FMI037 24GMF547 24IMA891 24JME621 DYNJ82220D UDI-DI 10198459103377 (EA) 40198459103378 (CS) LOT 24LMC859 DYNJ0429121M UDI-DI 10195327675813 (EA) 40195327675814 (CS) LOTS 24DMA039 24DMG180 24EMH743 24IMF503 DYNJ62745A UDI-DI 10195327686222 (EA) 40195327686223 (CS) LOTS 24KBR735 24LBK675 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0101287M lots 25BMC014; DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823; DYNJ0429339M lots 25AMI338 25BMI962 25DMG132; DYNJ0774005I lots 25ABU445 25EBJ726; DYNJ0774026K lots 25ABL910 25CBC859; DYNJ0842478M lots 25BMD033; DYNJ0842499L lots 25ADA394 25ADB067 25BDB213; DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723; DYNJ0843063M lots 24KDA944 25BMC710 25CMB746; DYNJ0843121L lots 25BMA139 25BMG893; DYNJ0843339P lots 25AMC… (truncated, 5722 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 February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ0220880V, DYNJ30077D CATH LAB ANGIO PACK-LF DYNJ0545064X CATH LAB PACK DYNJ39057C FEMORAL ANGIOGRAPY SET UP DYNJ61015B RAD-ANGIO PACK DYNJ47710C SURGERY ANGIO PACK-LF PHS677784013A

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
Full report

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

Recall #:
98601
Lot/product code:
DYNJ51126 UDI-DI 10889942122820 (EA) 40889942122821 (CS) LOT 20ADA585 DYNJ32555C UDI-DI 10193489859485 (EA) 40193489859486 (CS) LOTS 21HMF699 21IMF813 21JMA855 21KMD605 22DMB423 22FMD574 22HMB608 22LMA169 23BMA114 23EMB817 23EMG153 23KMB692 23KMH359 23LMH085 24AMC563 24CMD587 24DMD256 24DMG305 24FMD717 24IMI650 24JMC830 DYNJ66631 UDI-DI 10193489368321 (EA) 40193489368322 (CS) LOTS 22BBB494 22BBB497 DYNJ46153B UDI-DI 10193489853643 (EA) 40193489853644 (CS) LOTS 23EBM225 23FBC884 23HBP278 23IBV999 23KBC319 23LBK125 24CBF100 24DBE952 24FBP262 24GBN960 24HBO921 24IBO007 24IBU941 24JBK669 24LBK644 DYNJ26855F UDI-DI 10888277012042 (EA) 40888277012043 (CS) LOTS 20CBI049 20EBB600 20FBK900 20GBD331 20GBL795 20IBC788 20JBM786 20KBF148 21BBK244 21EBR327 21HBB849 21IBQ809 21OBA396 DYNJ24530I UDI- DI 10193489674910 (EA) 40193489674911 (CS) LOT 24ABU775 DYNJ0220880V UDI-DI 10889942054688 (EA) 40889942054689 (CS) LOTS 23HLA505 23HLB257 23JLA021 23JLA059 23KLA121 23KLA231 23KLA582 23LLA817 24ELA405 24ELA796 24HLA596 25AMI609 25BMH660 25CMA797 25DMF893 DYNJ30077D UDI-DI 10889942138630 (EA) 40889942138631 (CS) LOTS 23FBQ479 23LBL707 24CBC495 24EBQ346 24GBK895 24HBD023 24HBP290 24JBJ112 DYNJ0545064X UDI-DI 10193489747621 (EA) 40193489747622 (CS) LOTS 20BBL115 20CBA649 20DBB933 20DBP595 20HBW939 20KBI815 21ABK039 21ABK542 DYNJ39057C UDI-DI 10193489765519 (EA) 40193489765510 (CS) LOT 24BBD166 DYNJ61015B UDI-DI 10193489368888 (EA) 40193489368889 (CS) LOTS 23CMG023 23FBN151 DYNJ47710C UDI-DI 10889942214495 (EA) 40889942214496 (CS) LOTS 23FBF109 23GBB677 23JBP270 23LBO688 24DBD356 24FBP326 24IBC340 24KBJ788 PHS677784013A UDI-DI 10193489604337 (EA) 40193489604338 (CS) LOTS 20BBR301 20IMA683 21BMC467 21CMC052 21FMD140 21IMF229 22AMA959 22AME458 23GMA491 23GMD585 ***Updated 5/20/26 - The following lots were included in the customer notification but not in the FDA submission.*** DYNJ0220880V Lots 21DLA453 21FLA083 21ILA147 21KLA059 22ALA849 22DLA707 22FLA700 22HLA272 22ILA188 22ILA237 22ILA641 22JLA662 22KLA836 22KLA939 22LLA399 25KMB595 25LMA384; DYNJ30077D Lots 21ABB348 21ABR327 21DBQ397 21FBM873 21GBL539 21IBB390 21JBO220 21KBC302 21KBV079 21LBT528 22ABZ834 22DBD744 22EBG375 22JBK533 22KBO291 22OBM411 23ABD824 23ABO419 23DBB788 23EBS951 23HBB563 23IBG762 23JBT149 24CBR583; DYNJ32555C Lots 21DMA301 21DMD929 21EMB686 21FMA163 22KMD644 23AMB073 24LMH114 25BMA103 25BMD349; DYNJ46153B Lots 21CBL359 21FBE618 21GBF346 21HBQ716 21IBW154 21KBI853 21LBA401 22ABE877 22BBW978 22CBU323 22EBN725 22FBQ420 22GBJ229 22HBD581 22IBL258 22JBM061 22KBD440 22NBA199 23ABG769 23BBE724 25BBR850 25EBA187; DYNJ47710C Lots 21CBM120 21GBL622 21KBA849 21KBA925 22ABX239 22CBP654 22JBI023 22LBR933 23BBT611 25BBF414 25CBJ501; DYNJ61015B Lots 21AMB131 21BMB923 21BMC128 21CMD384 21DMD441 21FMD102 21GME205 21JMG652 22AMD050 22AME244 22DME869 22FMA872 22FMD246 22GMG534 22IMB779 22IMF574 22JMG963 23AMD815 23BMB886 23DMC707; DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
Full report

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

Recall #:
99062
Lot/product code:
DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)