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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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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

▸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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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 Temptations — Chocolatey 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

Lipofit — Lipofit 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

Kofinas — Garlic 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 Sprouts — Robust 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

Martina — Mangoes

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)

Recalls nationwide

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

19,422 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

ALL 50 STATES
▸Full report

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

Recall #:
98631
Lot/product code:
Lot Code: Model No. 3131; UDI-DI 00661392054271; Lot#6A3139, Expiration Date 01/21/2028 GTIN: (01)00661392054271(10)6A3139(17)280121
Recalling firm:
LSL Healthcare Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

ALL 50 STATES
▸Full report

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

Recall #:
98631
Lot/product code:
Lot Code: Model No. 7554; UDI-DI 00661392008342; Lot#6A3146, Expiration Date 01/22/2028 GTIN: (01)00661392008342(10)6A3146(17)280122
Recalling firm:
LSL Healthcare Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

ALL 50 STATES
▸Full report

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

Recall #:
98992
Lot/product code:
UDI: 4056869046877
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 9, 2026

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

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-0400-2026
Lot/product code:
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

ALL 50 STATES
▸Full report

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

Recall #:
98643
Lot/product code:
Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128
Recalling firm:
XTANT Medical Holdings, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

ALL 50 STATES
▸Full report

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

Recall #:
98631
Lot/product code:
Lot Code: Model No. 2925H; UDI-DI 00661392052635; Lot#6B3022, Expiration Date 11/30/2026 GTIN: (01)00661392052635(10)6B3022(17)261130
Recalling firm:
LSL Healthcare Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

There is a possibility of reagent leakage from the specimen container.

ALL 50 STATES
▸Full report

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

Recall #:
98632
Lot/product code:
UDI-DI: 08052478981055; Lot Number: 2024-09
Recalling firm:
Milestone S.R.L.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSoyUndeclaredRecalled March 9, 2026

Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN

Not listed on the label Soy.

FL
▸Full report

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

Recall #:
H-0623-2026
Lot/product code:
Lot #: 02/26/26 Expiration date:07/26/2026
Recalling firm:
South Florida Food, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

ALL 50 STATES
▸Full report

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

Recall #:
98992
Lot/product code:
ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 7, 2026

Philips Spectral CT on Rails. Model Number: 728334.

Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

ALL 50 STATES
▸Full report

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

Recall #:
98588
Lot/product code:
Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007.
Recalling firm:
PHILIPS MEDICAL SYSTEMS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 6, 2026

The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.

In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

ALL 50 STATES
▸Full report

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

Recall #:
98742
Lot/product code:
None provided.
Recalling firm:
Uvlizer c/o RAIS INTERNATIONAL LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled March 6, 2026

Doraditas de Azucar UPC 5901234123457

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

TX
▸Full report

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

Recall #:
H-0649-2026
Lot/product code:
All expiration dates
Recalling firm:
Distribuidora de Alimentos Sendero LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 6, 2026

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Software issue that renders the touch screen unresponsive.

ALL 50 STATES
▸Full report

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

Recall #:
98476
Lot/product code:
Model: C7000; UDI: 10381780126232; Serial Numbers: CHA1902101IE, CHA2001301IE, CHA2001401IE, CHA2002301IE, CHA2202301IE, CHA2305101IE, CHA2305401IE, CHA2307001IE, CHA2402201IE, CHB1711001IE, CHB1723601IE, CHB2000801IE, CHB2100901IE, CHB2301401IE, CHB2500101IE, CHC1800601IE, CHC1902601IE, CHC1902701IE, CHC2001201IE, CHD1705801IE, CHD1707101IE, CHD1801001IE, CHD1801101IE, CHD1902501IE , CHE1707201IE, CHE1707301IE, CHE2203301IE, CHE2204001IE, CHE2301001IE , CHE2305001IE, CHE2502901IE, CHE2503101IE, CHE2503201IE, CHE2503401IE, CHE2503701IE, CHF1701401IE, CHF1702701IE, CHF2100701IE, CHF2303701IE, CHF2305401IE, CHG1700101IE, CHG1700801IE, CHG1902401IE, CHG2000201IE, CHG2000301IE, CHG2204101IE, CHG2402301IE, CHG2502801IE, CHG2506001IE, CHH1802901IE, CHH2402801IE, CHH2500601IE, CHJ2001101IE, CHJ2001301IE , CHJ2301201IE, CHJ2304601IE, CHK1700801IE, CHK1702301IE, CHK1703001IE, CHK2402601IE, CHK2403401IE, CHK2404101IE, CHL1701701IE, CHL1900201IE, CHL2102901IE , CHL2103001IE, CHL2301301IE, CHL2302001IE, CHL2302101IE, CHL2403301IE, CHM1901901IE, CHM2100101IE, CHM2101601IE, CHM2200201IE, CHM2200301IE, CHM2200501IE, CHM2300701IE, CHM2402101IE.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 6, 2026

The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.

ALL 50 STATES
▸Full report

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

Recall #:
98747
Lot/product code:
None provided.
Recalling firm:
Uvlizer c/o RAIS INTERNATIONAL LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 6, 2026

Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

Not guaranteed to be germ-free

OR
▸Full report

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

Recall #:
D-0471-2026
Lot/product code:
Lot Number 01-27-2026@14S.5
Recalling firm:
PAYLESS COMPOUNDERS, LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodRecalled March 6, 2026

Gorditas de Azucar UPC 860010238134

Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy

TX
▸Full report

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

Recall #:
H-0648-2026
Lot/product code:
All expiration dates
Recalling firm:
Distribuidora de Alimentos Sendero LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
▸Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, UDI (01)00827002564244(17)261130(10)16288039, Lot Number 16288039; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, UDI (01)00827002210530(17)260430(10)16029543, Lot Number 16029543; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15681111, Lot Number 15681111; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15646726, Lot Number 15646726; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15721094, Lot Number 15721094; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15620729, Lot Number 15620729; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15583884, Lot Number 15583884; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15518185, Lot Number 15518185; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15473132, Lot Number 15473132; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15489080, Lot Number 15489080; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)261130(10)15971893, Lot Number 15971893; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15496527, Lot Number 15496527; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15484931, Lot Number 15484931; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251219(10)15466662, Lot Number 15466662; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260930(10)15970575, Lot Number 15970575; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16240911, Lot Number 16240911; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16042197, Lot Number 16042197; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16285631, Lot Number 16285631; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16402573, Lot Number 16402573; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16320650, Lot Number 16320650; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15899340, Lot Number 15899340; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270819(10)16360511, Lot Number 16360511; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16292003, Lot Number 16292003; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16205619, Lot Number 16205619; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270331(10)16191665, Lot Number 16191665; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270731(10)16300455, Lot Number 16300455; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16075768, Lot Number 16075768; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16454763, Lot Number 16454763; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16379974, Lot Number 16379974; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15878712, Lot Number 15878712; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15797112, Lot Number 15797112; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15832325, Lot Number 15832325; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260331(10)15796744, Lot Number 15796744; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260831(10)15841288, Lot Number 15841288; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, UDI (01)00827002444317(17)261130(10)16256021, Lot Number 16256021; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)270131(10)16368587, Lot Number 16368587; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)260430(10)16056219, Lot Number 16056219.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
▸Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260201(10)15476984X, Lot Number 15476984X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)261020(10)15719188X, Lot Number 15719188X; Reference Part Number C-PTISY-100-UNL-HC-G-NA, UDI (01)00827002577060(17)270814(10)16205108, Lot Number 16205108; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270528(10)16080161X, Lot Number 16080161X; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270901(10)16435112, Lot Number 16435112.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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

Recall #:
98495
Lot/product code:
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IM , UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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

Recall #:
98495
Lot/product code:
Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270221(10)NS15796862X, Lot Number NS15796862X; Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270301(10)NS15881832X, Lot Number NS15881832X.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

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

Recall #:
99331
Lot/product code:
Serial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL.
Recalling firm:
Daavlin Distributing Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

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

Recall #:
98512
Lot/product code:
1. UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352 2. UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352 3. UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351
Recalling firm:
Tornier, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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

Recall #:
98495
Lot/product code:
Reference Part Number C-NTSE-2.4-115-NC3, UDI (01)00827002362505(17)261103(10)15741134, Lot Number 15741134; Reference Part Number C-NTSE-2.4-115-NCT4, UDI (01)00827002362512(17)270118(10)15855141, Lot Number 15855141.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

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

Recall #:
98495
Lot/product code:
UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

ALL 50 STATES
▸Full report

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

Recall #:
98495
Lot/product code:
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)