BIGNOPE
Ko-fi

Recalls affecting Connecticut

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

16,745 recalls found
NewOld
High RiskLow Risk
AllClear

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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
▸Full report

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

Recall #:
98454
Lot/product code:
Model: 3005; UDI: 00821925035881; Lot Number: All unexpired
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled February 24, 2026

Imu-Tek Colostrum-5 Powder; 30% IgG,1,000 mg 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band exterior seal, 24 ounces (680 grams) powder, 7 38654 00052 6, ImuTek Laboratories, Fort Collins, CO 80524.

Product is potentially under-processed.

AKALAZCACOCTFLHIIAIDILINMAMDMOMSNCNENHNVNYOKORSCTNTXUTWAWIWY
▸Full report

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

Recall #:
H-0661-2026
Lot/product code:
Lot #22, 020528 Expiration
Recalling firm:
Imu-Tek Animal Health, Incorporated
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 24, 2026

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

Failed Dissolution Specifications

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-0399-2026
Lot/product code:
Lot #: 3116110, 3116130, Exp. Date 07/2026
Recalling firm:
MYLAN PHARMACEUTICALS INC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled February 24, 2026

Imu-Tek Colostrum-5 120 Capsules; 30% IgG, 2 capsules 2x/day, orally with 8 ounces of water, support a healthy immune system, 3 year shelf life, plastic bottle, inner liner seal and shrink band seal, 500 mg capsule, 7 38654 00026 7, Imu-Tek, Inc. Ft. Collins, CO 80524.

Product is potentially under-processed.

AKALAZCACOCTFLHIIAIDILINMAMDMOMSNCNENHNVNYOKORSCTNTXUTWAWIWY
▸Full report

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

Recall #:
H-0660-2026
Lot/product code:
Lot #013, 092826 Expiration
Recalling firm:
Imu-Tek Animal Health, Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

ALL 50 STATES
▸Full report

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

Recall #:
98498
Lot/product code:
Siemens Material Number (SMN): 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621;
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 23, 2026

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Surgical light assembly may not adequate support the weight of the ceiling cover.

ALL 50 STATES
▸Full report

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

Recall #:
98514
Lot/product code:
UDI: 07613327296167; All Lots
Recalling firm:
Stryker Communications
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

ALL 50 STATES
▸Full report

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

Recall #:
98481
Lot/product code:
REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK
Recalling firm:
Masimo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Radius VSM ECG pre-connected Set, REF: 4842, 4695

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.

ALL 50 STATES
▸Full report

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

Recall #:
98481
Lot/product code:
REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF
Recalling firm:
Masimo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 20, 2026

Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

ALL 50 STATES
▸Full report

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

Recall #:
98442
Lot/product code:
Lot Code: See Excel sheet attached named "FDA 5072 Product Information" See Spreadsheet attached named "FDA 5072 Product Quantity Distributed" Catalog Number: 53430108 (ELEGANCE 1 LEVEL CERVICAL PLATE 8MM) UDI-DI code: 03700780644353 Lot Numbers: PC03X R879X Catalog Number: 53430110 (ELEGANCE 1 LEVEL CERVICAL PLATE 10MM) UDI-DI code: 03700780644353 Lot Numbers: P758X RAA2X R825X R902X Catalog Number: 53430111 (ELEGANCE 1 LEVEL CERVICAL PLATE 11MM) UDI-DI code: 03700780644384 Lot Numbers: R194X RAA1X Catalog Number: 53430112 (ELEGANCE 1 LEVEL CERVICAL PLATE 12MM) UDI-DI code: 03700780644391 Lot Numbers: R195X RAB2X Catalog Number: 53430113 (ELEGANCE 1 LEVEL CERVICAL PLATE 13MM) UDI-DI code: 03700780644407 Lot Numbers: R196X R197X R584X RA81X Catalog Number: 53430114 (ELEGANCE 1 LEVEL CERVICAL PLATE 14MM) UDI-DI code: 03700780644414 Lot Number: R585X Catalog Number: 53430116 (ELEGANCE 1 LEVEL CERVICAL PLATE 16MM) UDI-DI code: 03700780644438 Lot Number: R586X Catalog Number: 53430120 (ELEGANCE 1 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Number: R182X Catalog Number: 53430220 (ELEGANCE 2 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Numbers: R587X RAA0X Catalog Number: 53430224 (ELEGANCE 2 LEVEL CERVICAL PLATE 24MM) UDI-DI code: 03700780644490 Lot Number: R588X Catalog Number: 53430228 (ELEGANCE 2 LEVEL CERVICAL PLATE 28MM) UDI-DI code: 03700780644513 Lot Numbers: R589X RA80X Catalog Number: 53430230 (ELEGANCE 2 LEVEL CERVICAL PLATE 30MM) UDI-DI code: 03700780644520 Lot Numbers: R556X RA99X Catalog Number: 53430232 (ELEGANCE 2 LEVEL CERVICAL PLATE 32MM) UDI-DI code: 03700780644537 Lot Numbers: R590X RAB3X Catalog Number: 53430234 (ELEGANCE 2 LEVEL CERVICAL PLATE 34MM) UDI-DI code: 03700780644544 Lot Numbers: R591X R880X RA98X Catalog Number: 53430236 (ELEGANCE 2 LEVEL CERVICAL PLATE 36MM) UDI-DI code: 03700780644551 Lot Numbers: R592X R881X RA97X RAU3X Catalog Number: 53430240 (ELEGANCE 2 LEVEL CERVICAL PLATE 40MM) UDI-DI code: 03700780644575 Lot Numbers: R593X RA96X Catalog Number: 53430338 (ELEGANCE 3 LEVEL CERVICAL PLATE 38MM) UDI-DI code: 03700780644582 Lot Numbers: R5B7X RAV7X Catalog Number: 53430344 (ELEGANCE 3 LEVEL CERVICAL PLATE 44MM) UDI-DI code: 03700780644605 Lot Numbers: R5B2X RAY6X Catalog Number: 53430347 (ELEGANCE 3 LEVEL CERVICAL PLATE 47MM) UDI-DI code: 03700780644612 Lot Numbers: R5B3X R8H4X RA95X Catalog Number: 53430350 (ELEGANCE 3 LEVEL CERVICAL PLATE 50MM) UDI-DI code: 03700780644629 Lot Numbers: R579X RA94X Catalog Number: 53430353 (ELEGANCE 3 LEVEL CERVICAL PLATE 53MM) UDI-DI code: 03700780644636 Lot Number: R5B0X Catalog Number: 53430356 (ELEGANCE 3 LEVEL CERVICAL PLATE 56MM) UDI-DI code: 03700780644643 Lot Numbers: R5B1X R5B6X RB63X Catalog Number: 53430362 (ELEGANCE 3 LEVEL CERVICAL PLATE 62MM) UDI-DI code: 03700780644667 Lot Number: R594X
Recalling firm:
Clariance-SAS
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 19, 2026

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

Failed Tablet/Capsule Specifications

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0401-2026
Lot/product code:
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Recalling firm:
Radnostix
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2026

Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.

ALL 50 STATES
▸Full report

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

Recall #:
98402
Lot/product code:
Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403
Recalling firm:
AMO Puerto Rico Manufacturing, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 18, 2026

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

Stability Data Does Not Support Expiry Date.

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-0386-2026
Lot/product code:
Lot #: 807CP-0003, Exp. Date 07/31/2026.
Recalling firm:
HTO Nevada Inc. dba Kirkman
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 18, 2026

Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

ALL 50 STATES
▸Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0382-2026
Lot/product code:
Lot #: 5GJ0223, Exp 04/30/2027
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSesameUndeclaredRecalled February 18, 2026

Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

Not listed on the label sesame seed ingredient in hamburger buns.

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 #:
H-0603-2026
Lot/product code:
Expiration date: 02/24/2026
Recalling firm:
NRS Enterprises, Inc. dba Sunflour Bakery
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.

ALL 50 STATES
▸Full report

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

Recall #:
98453
Lot/product code:
UPC: 0-24291-25607-6, UDI-DI: 00024291256076
Recalling firm:
Navajo Manufacturing Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).

Increased risk of purge leaks with Generation 1 purge cassettes.

ALL 50 STATES
▸Full report

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

Recall #:
98395
Lot/product code:
1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001 (GTIN: 00813502011999). 4. Product Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Product Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Product Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Product Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749, 2024328752, 2024328755, 2024328760, 2024328762, 2024328764, 2024328767, 2024328778, 2024328780, 2024328782, 2024328785, 2024328788, 2024328790, 2024328792, 2024328795, 2024328798, 2024328801, 2024328878, 2024328879, 2024328880, 2024328881, 2024328892, 2024328893, 2024328894, 2024328896, 2024328897, 2024328898, 2024328912, 2024328913, 2024328914, 2024328915, 2024328917, 2024328919, 2024328920, 2024328922, 2024328923, 2024328924, 2024329278, 2024329279, 2024329281, 2024329477, 2024329492, 2024329497, 2024329504, 2024329506, 2024329508, 2024329511, 2024329513, 2024329517, 2024329521, 2024329540, 2024329577, 2024329581, 2024329595, 2024329600, 2024329610, 2024329616, 2024329623, 2024329640, 2024329645, 2024329688, 2024329689, 2024329690, 2024329695, 2024329697, 2024329698, 2024329701, 2024329702, 2024329704, 2024329709, 2024329816, 2024329820, 2024329821, 2024329827, 2024329829, 2024329838, 2024329840, 2024329843, 2024329846, 2024329849, 2024330386, 2024330389, 2024330391, 2024330395, 2024330396, 2024330420, 2024330422, 2024330423, 2024330425, 2024330427, 2024330753, 2024330754, 2024330755, 2024330756, 2024330757, 2024330758, 2024330759, 2024330760, 2024331236, 2024331237, 2024331240, 2024331241, 2024331242, 2024331243, 2024331245, 2024331247, 2024331248, 2024331249, 2024331262, 2024331263, 2024331264, 2024331265, 2024331266, 2024331268, 2024331270, 2024331271, 2024331276, 2024331277, 2024331282, 2024331293, 2024331294, 2024331296, 2024331297, 2024331299, 2024331303, 2024331305, 2024331309, 2024331312, 2024331314, 2024331318, 2024331319, 2024331322, 2024331323, 2024331324, 2024331325, 2024331326, 2024331328, 2024331329, 2024331331, 2024331352, 2024331355, 2024331360, 2024331361, 2024331363, 2024331633, 2024331638, 2024331642, 2024331644, 2024331661, 2024331664, 2024331666, 2024331670, 2024331672, 2024331676, 2024331756, 2024331757, 2024331759, 2024331762, 2024331763, 2024331764, 2024331765, 2024331766, 2024331770, 2024331771, 2024331782, 2024331783, 2024331784, 2024331785, 2024331874, 2024331875, 2024331877, 2024331878, 2024331880, 2024331881, 2024331883, 2024331884, 2024331885, 2024331886, 2024332124, 2024332126, 2024332128, 2024332134, 2024332135, 2024332136, 2024332138, 2024332139, 2024332140, 2024332141, 2024332239, 2024332244, 2024332247, 2024332251, 2024332255, 2024332266, 2024332295, 2024332321, 2024332324, 2024332326, 2024332355, 2024332358, 2024332362, 2024332366, 2024332368, 2024332369, 2024332370, 2024332371, 2024332372, 2024332373, 2024332495, 2024332497, 2024332498, 2024332499, 2024332500, 2024332501, 2024332502, 2024332505, 2024332508, 2024332509, 2024332513, 2024332514, 2024332515, 2024332516, 2024332518, 2024332520, 2024332522, 2024332524, 2024332525, 2024332527, 2024332533, 2024332534, 2024332535, 2024332537, 2024332538, 2024332541, 2024332544, 2024332545, 2024332547, 2024332549, 2024332553, 2024332555, 2024332556, 2024332557, 2024332558, 2024332559, 2024332561, 2024332562, 2024332563, 2024332564, 2024332571, 2024332573, 202433257… (truncated, 345180 characters total — see the official FDA record for the full value)
Recalling firm:
Abiomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell Gamma Knife Elekta Esprit Leksell Gamma Knife (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.

Due to adapter not being properly aligned or locked in place.

ALL 50 STATES
▸Full report

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

Recall #:
98443
Lot/product code:
Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/11999-001/6126 LGK Perfexion/10917-004/6128 LGK Perfexion/17357-001/6130 LGK Perfexion/10394-LGK01/6144 LGK Perfexion/30002934-ENS/6160 LGK Perfexion/10583-LGK002/6161 LGK Perfexion/16867-001/6166 LGK Perfexion/10929-LGK002/6175 LGK Perfexion/10424-001/6182 LGK Perfexion/17539-001/6185 LGK Perfexion/11377-003/6186 LGK Perfexion/16647-001/6187 LGK Perfexion/11733-001/6192 LGK Perfexion/10960-005/6193 LGK Perfexion/21061-001/6195 LGK Perfexion/11439-002/6196 LGK Perfexion/30000655-001/6199 LGK Perfexion/11731-005/6200 LGK Perfexion/11149-LGK002/6206 LGK Perfexion/11077-007/6207 LGK Perfexion/30001910-001/6208 LGK Perfexion/13514-001/6211 LGK Perfexion/10979-002/6213 LGK Perfexion/10208-003/6215 LGK Perfexion/11127-009/6219 LGK Perfexion/30000732-001/6223 LGK Perfexion/30001270-001/6225 LGK Perfexion/11420-001/6228 LGK Perfexion/30001527-001/6231 LGK Perfexion/10879-LGK002/6234 LGK Perfexion/10698-001/6237 LGK Perfexion/10711-002/6243 LGK Perfexion/10148-LGK002/6245 LGK Perfexion/12748-LGK001/6248 LGK Perfexion/11536-LGK002/6251 LGK Perfexion/10567-044/6253 LGK Perfexion/10425-LGK002/6254 LGK Perfexion/11434-LGK002/6255 LGK Perfexion/13031-LGK/6256 LGK Perfexion/11006-LGK002/6259 LGK Perfexion/30000722-003/6261 LGK Perfexion/10537-LGK002/6264 LGK Perfexion/30001107-002/6265 LGK Perfexion/10630-002/6266 LGK Perfexion/11524-002/8001 LGK Perfexion/12643-001/8010 LGK Perfexion/30003042-001/8011 LGK Perfexion/11695-LGK002/8015 LGK Perfexion/11322-002/8028 LGK Perfexion/10700-LGK002/8044 LGK Perfexion/12957-003/8053 LGK Perfexion/11787-003/8059 LGK Perfexion/30000346-001/8065 LGK Perfexion/30004796-RS001/8078 LGK Perfexion/11131-LGK002/8098 LGK Perfexion/13252-LGK001/8106 LGK Perfexion/30000269-LGK001/8109 LGK Perfexion/15490-003/8124 LGK Perfexion/30002079-LGK001/8180 07340048305587 (Icon) Product and Serial Numbers: LGK Icon/30004749-LGK001/8099 LGK Icon/14750-LGK001/8083 LGK Icon/12579-007/6250 LGK Icon/18850-500/8005 LGK Icon/11920-C5210/6088 LGK Icon/30004694-003/8064 LGK Icon/30000718-002/6246 LGK Icon/30004889-LGK001/8087 LGK Icon/14765-003/8027 LGK Icon/12473-003/6005 LGK Icon/12274-014/6209 LGK Icon/10611-001/6081 LGK Icon/11720-002/6143 LGK Icon/12846-004/6064 LGK Icon/12242-003/8085 LGK Icon/30005412-002/8114 LGK Icon/12178-002/8002 LGK Icon/12685-007/8105 LGK Icon/10545-009/8072 LGK Icon/12926-001/6212 LGK Icon/14915-003/6236 LGK Icon/30004236-003/8117 LGK Icon/30002968-004/8030 LGK Icon/12668-008/8178 LGK Icon/14983-500/6076 LGK Icon/11916-001/8056 LGK Icon/11083-HOM001/6070 LGK Icon/15554-001/8103 LGK Icon/15661-502/8121 LGK Icon/10247-002/6136 LGK Icon/30000736-003/8108 LGK Icon/30005910-001/8127 LGK Icon/11676-003/8040 LGK Icon/11976-502/8035 LGK Icon/11868-008/6131 LGK Icon/12947-003/8122 LGK Icon/11290-ENS1/6174 LGK Icon/18464-003/8066 LGK Icon/10795-K08002/6063 LGK Icon/30004024-RS01/6201 LGK Icon/11291-001/6018 LGK Icon/10326-003/6105 LGK Icon/21121-002/8067 LGK Icon/10783-003/8077 LGK Icon/30004796-RS001/8078 LGK Icon/30006128-500/8112 LGK Icon/30004887-LGK001/8069 LGK Icon/30006248-500/8125 LGK Icon/30000656-500/6227 LGK Icon/17414-004/8043 LGK Icon/17525-002/6038 LGK Icon/12629-003/6026 LGK Icon/15514-003/8034 LGK Icon/17522-001/6214 LGK Icon/20438-003/6013 LGK Icon/10416-LGK001/6125 LGK Icon/15748-LGK001/6106 LGK Icon/11019-LGK002/8071 LGK Icon/10997-LGK001/6087 LGK Icon/10832-LGK002/8115 LGK Icon/11992-LGK002/8029 LGK Icon/10654-LGK002/8100 LGK Icon/14900-LGK001/6058 LGK Icon/11230-LGK002/8025 LGK Icon/12958-LGK002/8096 LGK Icon/11639-LGK001/6042 LGK Icon/13480-LGK003/8095 LGK Icon/11892-LGK002/8057 LGK Icon/11414-LGK002/6205 LGK Icon/11986-LGK003/8088 LGK Icon/11143-LGK002/6257 LGK Icon/11991-LGK003/8084 LGK Icon/10362-LGK002/8039 LGK Icon/10959-LGK001/6132 LGK Icon/11784-LGK001/6055 LGK Icon/10648-LGK001/6098 LGK Icon/10514-LGK002/6183 LGK Icon/30000333-LGK002/8119 LGK Icon/10103-LGK02/6149 LGK Icon/30001254-001/8092 LGK Icon/10104-LGK002/8046 LGK Icon/11530-001/6101 LGK Icon/19100-LGK001/8033 LGK Icon/10234… (truncated, 9706 characters total — see the official FDA record for the full value)
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package

Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.

ALL 50 STATES
▸Full report

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

Recall #:
98439
Lot/product code:
Lot Code: " Product Code: HKO " Version or Model: 901029 " Catalog Number: VS100 " Company Name: WELCH ALLYN, INC. " Primary DI Number: 00732094214154 " Packaging DI Number: 00732094212228 " Device Description: VS100 UDI BASE UNIT " Software version: 3.2.0.1 " Serial Numbers: Refer to attached Affected Product Table
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

Due to product exhibiting potential to generate either invalid or false negative results.

ALL 50 STATES
▸Full report

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

Recall #:
98441
Lot/product code:
Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box: UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068
Recalling firm:
Hologic, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
10081317028335
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

ALL 50 STATES
▸Full report

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

Recall #:
98482
Lot/product code:
00081317006671 00081317006794 00081317006800
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)