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Recalls affecting Alaska

Data last updated: September 9, 2026 at 1:18 PM UTC

16,261 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled March 11, 2026

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.

ALL 50 STATES
Full report

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

Recall #:
98653
Lot/product code:
US: Basic UDI Number 0763000B000262284, GTIN: 00763000871741; 00763000973391; 00763000973506; 00763000993269; 00199150003709. OUS: 00763000871734; 00763000973384; 00763000973513; 00763000811341; 00763000911515; 00763000963675; 00199150003716. Serial Numbers: 227076469, 2301234000, 2301321000, 2301373000, 2301543000, 2301547000, 2301551000, 2301552000, 2301556000, 2301558000, 2301559000, 2301560000, 2301709000, 0012573781, 0012576276, 0012578858, 0012583026, 0012583027, 0012590913, 0012590914, 0012594540, 0012594541, 0012609253, 0012609255, 0012609258, 0012614806, 0012614807, 0012614808, 0012619893, 0012619896, 0012619898, 0012619899, 0012623987, 0012623988, 0012623991, 0012631219, 0012631220, 0012631221, 0012631222, 0012635279, 0012635281, 0012635282, 0012635283, 0012635284, 0012641293, 0012641294, 0012641295, 0012641297, 0012643392, 0012643393, 0012643396, 0012643399, 0012645205, 0012645206, 0012645208, 0012655005, 0012655006, 0012655008, 0012655009, 0012655010, 0012655011, 0012655012, 0012655013, 0012655014, 0012655015, 0012655016, 0012655017, 0012665669, 0012665670, 0012665671, 0012665673, 0012665674, 0012665675, 0012670372, 0012670375, 0012670377, 0012670380, 0012670381, 0012670383, 0012672152, 0012672156, 0012672157, 0012672158, 0012672159, 0012672160, 0012672161, 0012672162, 0012672163, 0012672164, 0012672166, 0012672167, 0012681148, 0012681149, 0012681151, 0012681152, 0012681153, 0012681154, 0012681155, 0012681157, 0012681159, 0012681160, 0012685946, 0012685947, 0012685948, 0012685950, 0012685951, 0012685952, 0012685953, 0012685954, 0012685955, 0012688084, 0012690714, 0012690716, 0012690717, 0012690719, 0012690731, 0012690732, 0012690733, 0012690735, 0012690736, 0012690737, 0012690738, 0012690739, 0012699686, 0012699687, 0012699688, 0012699689, 0012699691, 0012699693, 0012699694, 0012699695, 0012699696, 0012699697, 0012699698, 0012699699, 0012703730, 0012703731, 0012703732, 0012703733, 0012703734, 0012703735, 0012703736, 0012703737, 0012703740, 0012703741, 0012703743, 0012703744, 0012705502, 0012705503, 0012705504, 0012705505, 0012705506, 0012705507, 0012705508, 0012705509, 0012705510, 0012705512, 0012716663, 0012716664, 0012716665, 0012716666, 0012716667, 0012716668, 0012716669, 0012716670, 0012716671, 0012716672, 0012716673, 0012716674, 0012724581, 0012724583, 0012724605, 0012724606, 0012724607, 0012724608, 0012724609, 0012724610, 0012724612, 0012724613, 0012728680, 0012728681, 0012728682, 0012728684, 0012728686, 0012728688, 0012728689, 0012740819, 0012740820, 0012740821, 0012740823, 0012740824, 0012740825, 0012740855, 0012740856, 0012740857, 0012740858, 0012743381, 0012743382, 0012743384, 0012743385, 0012743386, 0012743387, 0012743388, 0012743389, 0012743390, 0012743393, 0012743495, 0012743496, 0012752332, 0012752333, 0012752334, 0012752335, 0012752336, 0012752337, 0012752338, 0012752340, 0012752341, 0012754564, 0012754565, 0012754566, 0012754567, 0012754568, 0012754569, 0012754570, 0012754571, 0012758280, 0012758281, 0012758282, 0012758285, 0012758286, 0012758287, 0012758288, 0012758289, 0012760403, 0012760404, 0012760405, 0012760406, 0012760407, 0012760408, 0012760409, 0012760411, 0012762277, 0012762278, 0012762279, 0012762280, 0012762281, 0012762282, 0012762283, 0012762284, 0012765019, 0012765020, 0012777959, 0012777961, 0012777962, 0012777964, 0012777965, 0012777985, 0012777986, 0012777987, 0012777989, 0012777991, 0012781703, 0012783280, 0012783281, 0012783282, 0012783283, 0012783284, 0012783285, 0012783286, 0012783288, 0012783293, 0012783298, 0012784425, 0012784426, 0012784427, 0012784428, 0012784429, 0012784430, 0012784431, 0012784432, 0012784433, 0012784434, 0012794827, 0012794828, 0012794829, 0012794831, 0012794832, 0012794833, 0012794835, 0012794836, 0012794837, 0012794839, 0012794840, 0012794849, 0012794850, 0012794851, 0012794854, 0012794855, 0012794856, 0012794857, 0012794858, 0012794860, 0012794861, 0012794863, 0012794864, 0012794865, 0012794866, 0012794867, 0012794868, 0012794869, 0012794870.0012794871, 0012794872, 0012794873, 0012794874, 0012794875, 0012794876, 0012794877, 0012794878, 0012794879, 0012794897, 0012794898, 0012794900, 0012794948, 0012794952, 0012794953, 0012794954, 0012794955, 0012794956, 0012800168, 0012800175, 0012800184, 0012800185, 0012802040, 0012802043, 0012802044, 0012802046, 0012802111, 0012802113, 0012802114, 0012802115, 0012804219, 0012804220, 0012804221, 0012804223, 0012804225, 0012804226, 0012804227, 0012804228, 0012824948, 0012824949, 0012824950, 0012824951, 0012824952, 0012824955, 0012830178, 0012830179, 0012830180, 0012830181, 0012830182, 0012830183, 0012830184, 0012830185, 0012830186, 0012834156, 0012834157, 0012834158, 0012834162, 0012834166, 0012834167, 0012834168, 0012834169, 0012834170, 0012834171, 0012837948, 0012837949, 0012838052, 0012838053, 0012838054, 0012838055, 0012840611, 0012840614, 0012840615, 0012840616, 0012840618, 0012840619, 0012843009, 0012843010, 0012843011, 0012843012, 0012843013, 0012843014, 0012845157, 0012845158, 00128… (truncated, 27239 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 11, 2026

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.

Not guaranteed to be germ-free

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-0430-2026
Lot/product code:
Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 11, 2026

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

ALL 50 STATES
Full report

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

Recall #:
98618
Lot/product code:
Product code:ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 Batch Number: 33F25K0409
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 11, 2026

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

ALL 50 STATES
Full report

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

Recall #:
98618
Lot/product code:
Product Code: ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
Recalling firm:
ARROW INTERNATIONAL, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 10, 2026

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.

ALL 50 STATES
Full report

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

Recall #:
98542
Lot/product code:
UDI-DI: 05055982787758 and 05055982787710 Serial Number: P0911221 P0909831 P0925191 P0907166 P0901255 P0906820 P0925431 P0912820 P0924568 P0910471 P0903999 P0914725 P0909539 P0910797 P0896659 P0911350 P0925190 P0914588 P0904321 P0905040 P0924559 P0913229 P0909537 P0923376 P0923377 P0911222 P0899348 P0909201 P0900805 P0912570 P0903592 P0912571 P0912573 P0914003 P0900806 P0910470 P0907737 P0907738 P0914004 P0908250 P0908429 P0914122 P0916220 P0912343 P0912821 P0924239 P0925203 P0925433 P0903476 P0912342 P0913326 P0904320 P0905039 P0897003 P0915180 P0898734 P0907165 P0907736 P0897841 P0903997 P0925432 P0896658 P0915498 P0914724 P0915163 P0913227 P0914118 P0908428 P0908768 P0914121 P0912572 P0915500 P0909200 P0911602 P0909202 P0912341 P0906821 P0899349 P0905354 P0905355 P0905356 P0905980 P0914726 P0908251 P0916221 P0910795 P0907167 P0907507 P0914589 P0897247 P0914587 P0903591 P0911601 P0903477 P0913228 P0910796 P0908430 P0903998 P0904319 P0904739 P0904740 P0899214 P0923462 P0905041 P0911603 P0907505 P0907506 P0898735 P0901254 P0912822 P0909830 P0910469 P0914586 P0899215 P0900415 P0897002 P0897248 P0914002 P0897842
Recalling firm:
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 10, 2026

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

ALL 50 STATES
Full report

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

Recall #:
98675
Lot/product code:
ARTIS pheno UDI: 4056869046877. 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 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)
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 9, 2026

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

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. 1555; UDI-DI 00661392002326; Lot# 260221, Expiration Date 02/28/2027 GTIN: (01)00661392002326(10)260221(17)270228
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)
UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

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. 2717J; UDI-DI 00661392054721; Lot# 6A3043, Expiration Date 11/30/2026. Lot#6B3076, Expiration Date 01/31/2027 GTIN: (01)00661392054721(10)6A3043(17)261130 GTIN: (01)00661392054721(10)6B3076(17)260131
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

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)
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
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

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

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

Recall #:
98631
Lot/product code:
Lot Code: Model No. 2717H; UDI-DI 00661392054738; Lot# 6A3181; Expiration Date 11/30/2026 GTIN: (01)00661392054738(10)6A3181(17)261130
Recalling firm:
LSL Healthcare Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled March 9, 2026

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.

Due to complaints of device breakage at the traction force gauge to handle joint.

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

Recall #:
98597
Lot/product code:
Model/Catalog Number: VAC-6000MT UDI: 00814247020642 Lot Code: 251327 251333 251328 251330 251370 251388 251545 251546 251582 251583 251680 251681
Recalling firm:
Clinical Innovations, LLC
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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.

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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.
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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.

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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
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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.

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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
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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.

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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)
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.

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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)
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UnclassifiedRisk not yet known
Medical deviceRecalled March 5, 2026

Photera 400, 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: 4-01440NB10CL, 2 4-01441NB10CL.
Recalling firm:
Daavlin Distributing Company
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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
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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).

ALL 50 STATES
Full report

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)