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Recalls affecting Wyoming

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

16,268 recalls found
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Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
FoodForeign materialRecalled March 3, 2026

Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

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

Recall #:
H-0600-2026
Lot/product code:
Best By Dates: 10/13/2026 12/13/2026 3/7/2027
Recalling firm:
Ajinomoto Foods North America 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
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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 March 2, 2026

Philips Respironics Trilogy EV300, 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 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 Evo, 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)
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.

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.

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 IIModerate risk
DrugRecalled March 2, 2026

Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

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-0390-2026
Lot/product code:
Lot: 7261973A, 7261974A, Exp 01/31/2027
Recalling firm:
STRIDES PHARMA INC
View official FDA record (opens in a new tab)
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 February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472

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:
Medline SKU # DYNJ84472, UDI/DI each 10195327369286, UDI/DI case 40195327369287, Lot Numbers: 23LBN016, 23KBL255, 23HBL885, 23FBV799.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

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 # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

ALL 50 STATES
▸Full report

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

Recall #:
98374
Lot/product code:
Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401, 1496-224402, 1496-224403, 1496-224404, 1496-224405, 1496-224406, 1496-223850, 1496-223851, 1496-223852, 1496-224448, 1496-224956, 1496-224957, 1496-224958, 1496-224959, 1496-224960, 1496-224961, 1496-224981, 1496-224258, 1496-223595, 1496-223596, 1496-223597, 1496-223598, 1496-223619, 1496-223620, 1496-223621, 1496-223622, 1496-223623, 1496-223624, 1496-224717, 1496-224718, 1496-223854, 1496-224373, 1496-224374, 1496-223894, 1496-223895, 1496-223896, 1496-223897, 1496-223898, 1496-223899, 1496-223900, 1496-223901, 1496-223902, 1496-223903, 1496-223904, 1496-223905, 1496-223906, 1496-223907, 1496-223918, 1496-225043, 1496-225044, 1496-225045, 1496-225046, 1496-225047, 1496-225048, 1496-225049, 1496-225050, 1496-225051, 1496-225052, 1496-225053, 1496-225054, 1496-225055, 1496-225056, 1496-225057, 1496-225058, 1496-225059, 1496-225060, 1496-225061, 1496-225062, 1496-225063, 1496-225064, 1496-225065, 1496-225066, 1496-225067, 1496-225068, 1496-224949, 1496-223760, 1496-223761, 1496-225154, 1496-224639, 1496-224719, 1496-224720, 1496-224721, 1496-225088, 1496-225089, 1496-224672, 1496-223908, 1496-223909, 1496-223910, 1496-223911, 1496-223912, 1496-223913, 1496-223914, 1496-223915, 1496-223916, 1496-223917, 1496-224637, 1496-224638, 1496-224752, 1496-224744, 1496-224745, 1496-224746, 1496-224747, 1496-224407, 1496-224408, 1496-224409, 1496-224410, 1496-224411, 1496-224412, 1496-224413, 1496-224414, 1496-224415, 1496-224416, 1496-224417, 1496-224418, 1496-224419, 1496-224420, 1496-224421, 1496-224753, 1496-224754, 1496-224755, 1496-224756, 1496-224757, 1496-225129, 1496-223825, 1496-223826, 1496-223829, 1496-223830, 1496-223831, 1496-223832, 1496-223833, 1496-223834, 1496-223835, 1496-223836, 1496-223837, 1496-223838, 1496-223839, 1496-222928, 1496-222929, 1496-223774, 1496-223775, 1496-224063, 1496-224064, 1496-223580, 1496-223618, 1496-223313, 1496-223314, 1496-223315, 1496-223316, 1496-223317, 1496-223318, 1496-223319, 1496-223320, 1496-223321, 1496-223322, 1496-223323, 1496-223325, 1496-223326, 1496-223327, 1496-223328, 1496-223330, 1496-223331, 1496-223332, 1496-223333, 1496-223334, 1496-223335, 1496-223336, 1496-223337, 1496-223338, 1496-223339, 1496-223340, 1496-223341, 1496-223342, 1496-223419, 1496-223420, 1496-223421, 1496-223422, 1496-223423, 1496-223424, 1496-223425, 1496-223426, 1496-223427, 1496-223428, 1496-223429, 1496-223430, 1496-223431, 1496-223432, 1496-223433, 1496-223434, 1496-223435, 1496-223436, 1496-223437, 1496-223438, 1496-223439, 1496-223440, 1496-223441, 1496-223442, 1496-223443, 1496-223444, 1496-223445, 1496-223446, 1496-223447, 1496-223448, 1496-223449, 1496-223450, 1496-223451, 1496-223452, 1496-223453, 1496-223454, 1496-223455, 1496-223456, 1496-223457, 1496-223458, 1496-223459, 1496-223460, 1496-223461, 1496-223462, 1496-223463, 1496-223464, 1496-223465, 1496-223466, 1496-223467, 1496-223468, 1496-223469, 1496-223470, 1496-223471, 1496-223472, 1496-223473, 1496-223474, 1496-223475, 1496-223476, 1496-223477, 1496-223478, 1496-223479, 1496-223480, 1496-223481, 1496-223482, 1496-223483, 1496-223484, 1496-223485, 1496-223486, 1496-223487, 1496-223488, 1496-223489, 1496-223490, 1496-223491, 1496-223492, 1496-223493, 1496-223494, 1496-223495, 1496-223496, 1496-223497, 1496-223498, 1496-223499, 1496-223500, 1496-223501, 1496-223502, 1496-223503, 1496-223504, 1496-223505, 1496-223506, 1496-223507, 1496-223508, 1496-223509, 1496-223510, 1496-223511, 1496-223512, 1496-223513, 1496-223514, 1496-223515, 1496-223516, 1496-223517, 1496-223518, 1496-223519, 1496-223520, 1496-223521, 1496-223522, 1496-223523, 1496-223524, 1496-223525, 1496-223526, 1496-223527, 1496-223528, 1496-223529, 1496-223530, 1496-223531, 1496-223532, 1496-223533, 1496-223534, 1496-223535, 1496-223536, 1496-223537, 1496-223538, 1496-223539, 1496-223540, 1496-223541, 1496-223542, 1496-223543, 1496-223544, 1496-223545, 1496-223546, 1496-223547, 1496-224427, 1496-224428, 1496-224449, 1496-224450, 1496-224451, 1496-224452, 1496-224453, 1496-224454, 1496-224455, 1496-224456, 1496-224457, 1496-224458, 1496-224459, 1496-224460, 1496-224461, 1496-224462, 1496-224463, 1496-224464, 1496-224465, 1496-224466, 1496-224467, 1496-224468, 1496-224469, 1496-224470, 1496-224471, 1496-224472, 1496-224473, 1496-224474, 1496-224475, 1496-224476, 1496-224477, 1496-224478, 1496-224479, 1496-224480, 1496-224481, 1496-224482, 1496-224483, 1496-224484, 1496-224485, 1496-224486, 1496-224487, 1496-224488, 1496-224489, 1496-224490, 1496-224491, 1496-224492, 1496-224493, 1496-224494, 1496-224495, 1496-224496, 1496-224497, 1496-224498, 1496-224499, 1496-224500, 1496-224501, 1496-224502, 1496-224503, 1496-224504, 1496-224505, 1496-224506, 1496-224507, 1496-224508, 1496-224509, 1496-224510, 1496-224511, 1496-224512, 1496-224513, 1496-224514, 1496-224515, 1496-224516, 1496-224517, 1496-224518, 1496-224519, 1496… (truncated, 23324 characters total — see the official FDA record for the full value)
Recalling firm:
Spacelabs Healthcare, Inc.
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 ARTHROSCOPY PACK DYNJ45173D

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

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▸Full report

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

Recall #:
98601
Lot/product code:
DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
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. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A

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

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▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712 22FBU975 22IBD336 22LBH042 23BBG319 23CBW711 23EBF014 DYKM2130A UDI-DI 10195327630904 Lot 24ELA817 DYNJ0678934J UDI-DI 10195327637378 Lot 24FMI941 DYNJ23456J UDI-DI 10193489449839 Lot 21BMB927 DYNJ0842873K UDI-DI 10195327286613 Lots 22KDB463 23ADA210 23CDA339 23CDB773 23EDB190 23FDB457 23HDA476 23IDC327 23JDB182 23JDC057 24ADB081 24BDB286 24CDB934 24GDA042 24HDA590 24HDC238 DYNJ65925B UDI-DI 10193489925326 Lots 21FLA630 21GLA415 21HLA270 21JLA166 21KLA318 22CLA057 22CLA817 22DLA206 22ELA964 DYNJ65925C UDI-DI 10195327201371 Lots 23CLB075 23ELA853 23HLA442 23ILA022 DYNJ68037 UDI-DI 10193489473889 Lots 21ABT991 21HBL486 DYNJ901681D UDI-DI 10193489308099 Lot 24EMH538 DYNJ51853C UDI-DI 10193489269000 Lots 21CBB992 21DBA936 21FBE790 21HBN274 21KBA699 21KBP057 DYNJ51853D UDI-DI 10195327101336 Lots 22EBB104 22HBF054 22IBE507 22JBJ069 22KBS971 22LBT245 22NBG258 22OBI766 23ABI851 DYNJ60606A UDI-DI 10193489693386 Lot 24BBA469 DYNJ40952A UDI-DI 10193489941906 Lots 21GBR992 21JBX464 22BBS266 22CBP195 22EBS044 DYNJVB1303A UDI-DI 10193489928358 Lots 23ELB088 23FLA355 DYNJ0780143K UDI-DI 10195327477240 Lot 24AMI797 DYNJ0101291D UDI-DI 10193489381931 Lots 21CDC066 21EDB518 21GDC932 21HDC814 22BDA495 22DDB731 22DDC457 22EDB642 22GDA964 22JDA001 22JDC181 DYNJ69172 UDI-DI 10193489899603 Lots 21GMA692 21IMH791 DYNJ69172B UDI-DI 10195327487027 Lot 23KMC637 DYNJ57543F UDI-DI 10195327279028 Lot 23AMF931 DYNJ57543I UDI-DI 10195327359362 Lot 23CMD266 DYNJ57543J UDI-DI 10195327416027 Lots 23GMD945 23GMG266 DYNJ61702A UDI-DI 10193489470321 Lots 21CBN901 21FBM858 21GBE705
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. KIT NEURO CSTM SAMP0551

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

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▸Full report

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

Recall #:
99062
Lot/product code:
SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361
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. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B

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:
DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281 Lot 21HLA726 DYNJ35110D UDI-DI 10193489329940 Lot 21IMC537 DYNJ44293D UDI-DI 10193489833416 Lots 21CBE250 21CBX084 21FBB546 21HBD075 21KBN509 22ABV463 22BBX022 22DBJ641 22HBB710 22HBT960 22IBD236 22OBF392 DYNJ0854485T UDI-DI 10193489864199 Lots 21FBC416 21GBL506 21IBO920 21JBS587 DYNJ35916J UDI-DI 10193489838404 Lots 21CBF463 21DBP668 21DBR247 DYNJ57760B UDI-DI 10193489342581 Lots 21CME104 21EME408 21FMD506 21GMG028 21JMF774 21KMH487 DYNJ0842873J UDI-DI 10193489448917 Lots 21ADA204 21CDB566 21EDB709 21GDC532 21HDC041 21JDB401 21JDC566 21LDA726 22BDA893 22CDC138 22EDA075 22FDC040 22HDB149 22JDA080 DYNJ51126A UDI-DI 10193489854886 Lots 21DDA694 21EDB249 21GDD164 21IDA472 21KDA815 DYNJ62858B UDI-DI 10193489891263 Lots 21FMF601 21HMF637 21HMG835 21JMF531 DYNJ51127B UDI-DI 10193489854893 Lot 22FBV791
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.

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:
Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24FMF601; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24EMB438; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24BMA764; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23LME233; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23JMH698; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23IMD171; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23GMD850; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23FMF778; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 23EMG560; Medline SKU DYNJ47952B, UDI/DI each 10193489609851, UDI/DI case 40193489609852, Lot Number 25L… (truncated, 10705 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

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B

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:
DYNJ43609S UDI-DI 10195327322984 Lot 23BMG740; DYNJ67987D UDI-DI 10195327265496 Lot 22LMI014; DYNJ80317A UDI-DI 10195327410780 Lot 23JLA076 DYNJ38412C UDI-DI 10195327291792 Lot 24CME277 DYNJ66260A UDI-DI 10195327185749 Lot 22GMH445 DYNJ44293I UDI-DI 10198459152108 Lots 24JBX196 24KBJ077 24LBF062 24LBP058 DYNJ0854485W UDI-DI 10195327403430 Lot 23EMI244 DYNJ82709 UDI-DI 10195327202590 Lots 22KBG072 23ABM307 23ABR612 DYNJ0261554AL UDI-DI 10195327467760 Lot 23IMA846 DYNJ31103F UDI-DI 10195327461317 Lots 23ILA143 23JLA420 23KLB055 23LLA790 24ALA692 24BLA009 24BLA835 24CLA859 24ELA213 24ELA684 24FLA287 24GLA266 24HLA117 24HLB121 24JLA570 24KLB094 24LLA468 25ALA377 DYNJ83506 UDI-DI 10195327272890 Lot 22LBM317 DYNJ66366C UDI-DI 10195327232887 Lots 22HME111 22IME517 22JMF050 22LMH296 23DMD313 23EMF238 23FMH270 23GMF506 23HME060 SAMPC0686 UDI-DI 10195327195489 Lot 22HDA577 DYNJ63434B UDI-DI 10195327335502 Lots 23CBG406 23CBU167 23DBT002 23EBS228 DYNJ907758B UDI-DI 10195327181000 Lot 22GBD778 DYNJ80925B UDI-DI 10195327624903 Lot 24CBG978
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. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F

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:
DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416
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.

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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

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.

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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

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.

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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

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B

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

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▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)