FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 24 of 30

Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
Medline Industries, LP · Northfield, IL

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA
Class IIDeviceOngoing
Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc · Bethlehem, PA
Class IIDeviceOngoing
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Philips North America Llc · Cambridge, MA
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Boston Scientific Corporation · Saint Paul, MN
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Boston Scientific Corporation · Saint Paul, MN
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
Cardinal Health 200, LLC · Waukegan, IL
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
Cardinal Health 200, LLC · Waukegan, IL
Class IIDeviceOngoing
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21.
Class IIDeviceOngoing
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I; 4) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 5) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 6) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB12; 7) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB17; 8) KIT, OPEN HEART CON , Catalog Number: PVCGOHCOH; 9) KIT,OPEN HEART ADULT MDST , Catalog Number: PVCGOHCPA; 10) KIT, CABG , Catalog Number: PVHDCBAGK; 11) KIT, ORP CABG , Catalog Number: PVHDCGVCP; 12) KIT, ORP CABG , Catalog Number: PVHDCGV40; 13) KIT, VALVE , Catalog Number: PVHDVAAGH; 14) KIT, ORP VALVE , Catalog Number: PVHDVPVCQ; 15) KIT, ORP VALVE , Catalog Number: PVHDVPV43; 16) KIT, MAJOR CARDIAC , Catalog Number: PVOCMGJ36; 17) KIT, OPEN HEART DH , Catalog Number: PVOCOHNHE; 18) KIT, OPEN HEART , Catalog Number: PVOCOH12O; 19) KIT, CAROTID ENDARTERECTOMY , Catalog Number: PVVMCV07E; 20) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP22R; 21) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP245; 22) KIT, THORACIC BARNES JEWISH , Catalog Number: PVVMTH22J; 23) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO22R; 24) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO241; 25) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO242; 26) KIT, THORACIC , Catalog Number: PVVXTHLCG; 27) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10R; 28) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10S; 29) KIT, MAJOR VASC, PRESBYTERIAN , Catalog Number: PVV2MJ01M; 30) KIT, CARDIAC VALVE , Catalog Number: PVV207962; 31) KIT, CARDIAC VALVE , Catalog Number: PVV207963; 32) KIT, CARDIAC VALVE , Catalog Number: PVV207964; 33) KIT, CARDIAC CABG , Catalog Number: PVV293340; 34) KIT, CARDIAC CABG , Catalog Number: PVV293362; 35) KIT, CARDIAC CABG , Catalog Number: PVV293363; 36) KIT, PUH CARDIAC CABG , Catalog Number: PVX4CAP14; 37) KIT, PUH CARDIAC , Catalog Number: PVX4CRPR7; 38) KIT, EAS THORACIC ABDOMINAL , Catalog Number: PVX4THEAA; 39) KIT, CV , Catalog Number: PV15CGSPF; 40) KIT, CV , Catalog Number: PV15CGSPG; 41) KIT,MAJOR VASCULAR , Catalog Number: PV15MJSPD; 42) KIT, OPEN HEART SET UP , Catalog Number: PV24OHN29; 43) KIT, OPEN HEART , Catalog Number: PV29OHMME; 44) KIT, OPEN HEART , Catalog Number: PV3LOHSGJ; 45) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMYB; 46) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMY3; 47) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR47; 48) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR48; 49) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR49; 50) KIT, OPEN HEART , Catalog Number: PV40OHJUD; 51) KIT, MODULE OPEN HEART , Catalog Number: PV60OH15F; 52) CV W AUX PACK 2 OF 2 CMC , Catalog Number: SCVCGPAACD; 53) THORACIC ROBOTIC PACK CMC , Catalog Number: SCVCGTRACI; 54) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG17; 55) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG18; 56) CV PACK 2 OF 2 SHER , Catalog Number: SCVCGVCS16
Class IIDeviceOngoing
Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089
Class IFoodTerminated
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
Class IFoodOngoing
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
KHONG GUAN (HQ) · Union City, CA
Class IIFoodOngoing
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White Formulas, Inc. · Santa Rosa, CA
Class IIFoodOngoing
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Laurel, MD
Class IIFoodOngoing
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Laurel, MD
Class IFoodOngoing
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
ZMB Enterprises · Carlsbad, CA
Class IIFoodOngoing
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.
CUISINE, KETTLE · Savage, MD
Class IIFoodOngoing
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Laurel, MD
Class IIFoodOngoing
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125846.
Class IIFoodOngoing
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Laurel, MD
Class IIFoodOngoing
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125839.
Lidl US TRADING · Arlington, VA
Class IIFoodOngoing
Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT (Item 136990, UPC 742365002700) and 18 CT (Item 136917, UPC 742365208867). Tetra Pak Carton. Distributed by: Horizon Organic Dairy, LLC ( Horizon ) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening.
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Sep 9, 2026 · Z-3072-2026

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Reported Sep 9, 2026 · Z-3079-2026

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

Reported Sep 9, 2026 · Z-3086-2026

Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

Reported Sep 9, 2026 · Z-3089-2026

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Reported Sep 9, 2026 · Z-3052-2026

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

Reported Sep 9, 2026 · Z-3040-2026

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Reported Sep 9, 2026 · Z-3077-2026

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Reported Sep 9, 2026 · Z-3055-2026

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

Reported Sep 9, 2026 · Z-3083-2026

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Reported Sep 9, 2026 · Z-3076-2026

There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.

Reported Sep 9, 2026 · Z-3082-2026

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

Reported Sep 9, 2026 · Z-3096-2026

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

Reported Sep 9, 2026 · Z-3094-2026

AVID Medical, Inc. · Toano, VA

The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

Reported Sep 9, 2026 · Z-3045-2026

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Reported Sep 9, 2026 · Z-3062-2026

Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

Reported Sep 9, 2026 · Z-3067-2026

Cardinal Health 200, LLC · Waukegan, IL

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

Reported Sep 9, 2026 · Z-3098-2026

Medline Industries, LP · Northfield, IL

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Reported Sep 9, 2026 · Z-3063-2026

H & U Inc. dba Sun Noodle · Honolulu, HI

Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.

Reported Sep 2, 2026 · H-1258-2026

Undeclared peanuts.

Reported Sep 2, 2026 · H-1259-2026

Label does not declare walnuts in English

Reported Sep 2, 2026 · H-1278-2026

Foreign object: products may contain glass pieces

Reported Sep 2, 2026 · H-1265-2026

Foreign object: products may contain glass pieces

Reported Sep 2, 2026 · H-1266-2026

The product contains 1,4-DMAA, Phenylethylamine and Phenibut.

Reported Sep 2, 2026 · H-1263-2026

Product had a presumptive positive test result for Listeria monocytogenes

Reported Sep 2, 2026 · H-1271-2026

Foreign object: products may contain glass pieces

Reported Sep 2, 2026 · H-1264-2026

Lidl US TRADING · Arlington, VA

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).

Reported Sep 2, 2026 · H-1275-2026

Foreign object: products may contain glass pieces

Reported Sep 2, 2026 · H-1268-2026

The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).

Reported Sep 2, 2026 · H-1274-2026

Horizon Organic Dairy, LLC · Broomfield, CO

Product has the potential to be spoiled.

Reported Sep 2, 2026 · H-1333-2026