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 23 of 30

Class IIDeviceOngoing
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA

Complaints of blue-green discoloration in product

Class IIDeviceOngoing
Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A
Class IIDeviceOngoing
Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Baxter Healthcare Corporation · Deerfield, IL
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Baxter Healthcare Corporation · Deerfield, IL
Class IIDeviceOngoing
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ; 4) KIT, CRANIOTOMY PRESBYTERIAN , Catalog Number: PNV20101L; 5) KIT, LARGE SPINE 143487 , Catalog Number: PNV20101L; 6) FUSION ACCESSORY PACK BRO , Catalog Number: SNECGLFABB; 7) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSLHP; 8) LH GENERAL NEURO SPINE PACK , Catalog Number: SNEOCGSL20
Class IIDeviceOngoing
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
Class IIDeviceOngoing
Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520
Class IIDeviceOngoing
Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
Class IIDeviceOngoing
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
Class IIDeviceOngoing
Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010159C; 6) PEDS EMERGENCY TRAY-YELLOW, Catalog Number: ACC010160C; 7) PEDS EMERGENCY TRAY-WHITE, Catalog Number: ACC010161C; 8) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010162C; 9) PEDS EMERGENCY TRAY-RED, Catalog Number: ACC010163C; 10) CVHP DRAWER -IV, Catalog Number: ACC010308A; 11) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010316A; 12) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010318A; 13) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010319A; 14) DRAWER THREE - IV SET UP, Catalog Number: ACC010361; 15) DRAWER 1, Catalog Number: ACC010374A; 16) DRAWER 3 LAB DRAW & IV START, Catalog Number: ACC010417A; 17) DRAWER #6, Catalog Number: ACC010477B; 18) DRAWER #4, Catalog Number: ACC010479A; 19) ADULT DRAWER 4, Catalog Number: ACC010679; 20) DRAWER 2, Catalog Number: ACC010690; 21) DRAWER 2, Catalog Number: ACC010726; 22) DRAWER 2, Catalog Number: ACC010726A; 23) RRMC CODE CART DRAWER 3, Catalog Number: ACC010770; 24) DRAWER 2, Catalog Number: ACC010875; 25) BOTTOM DRAWER, Catalog Number: ACC010972; 26) CODE CART DRAWER TWO IV SUPPLI, Catalog Number: ACC010977; 27) DRAWER 4 CIRCULATION, Catalog Number: ACC011088; 28) NON-SUTURED SHEATH #113197 KIT, Catalog Number: DYKM1495; 29) SUTURED SHEATH W/SCI #113198, Catalog Number: DYKM1496; 30) LABOR TRIAGE KIT - LF #13232, Catalog Number: DYKM1564; 31) FINGER THORACOSTOMY PCC KIT, Catalog Number: DYKM2676A; 32) UVC KIT, Catalog Number: DYKM2677A; 33) CRIC KIT, Catalog Number: DYKM2678A; 34) SCOPE KIT 3, Catalog Number: DYKM2750; 35) SURGICAL KIT, Catalog Number: DYKM2752; 36) PRE OP KIT, Catalog Number: DYKS1022B; 37) MAC KIT, Catalog Number: DYKS1089B; 38) PRE OP KIT, Catalog Number: DYKS1091A; 39) PRE OP KIT, Catalog Number: DYKS1128B; 40) PRE OP KIT, Catalog Number: DYKS1325; 41) UCLA RAPID RESPONSE KIT, Catalog Number: DYLAB1097; 42) BSSM-WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3061; 43) WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3064; 44) WHOLE BLOOD/DOUBLE RED, Catalog Number: DYNDB3078C; 45) ACCESS KIT, Catalog Number: DYNDH1159A; 46) ADLT BLOOD CULTURE COLLECT KIT, Catalog Number: DYNDH1245; 47) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1362; 48) PEDIATRIC BLOOD CULTURE KIT, Catalog Number: DYNDH1363; 49) STANFORD TIME TO POSITIVITY, Catalog Number: DYNDH1591; 50) BLOOD CULTURE PINK PERIPHERAL, Catalog Number: DYNDV1875; 51) BLOOD CULTURE BLUE PERIPHERAL, Catalog Number: DYNDV1876; 52) NICU LINE PACK, Catalog Number: DYNJ63410; 53) STUDENT PRACTICE BAG W LOGO, Catalog Number: EDUC1043; 53)
Class IIDeviceOngoing
Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A
Class IIDeviceOngoing
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips North America Llc · Cambridge, MA
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D; 4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH; 5) KIT, GYN LAPAROSCOPY , Catalog Number: PBV2MJMVH; 6) KIT, GYN LAPAROSCOPY , Catalog Number: PB43LSEJG; 7) GYNE ROBOTIC PACK CMC , Catalog Number: SMACGGRACE; 8) LH GYN ROBOTICS PK , Catalog Number: SMAOCGYLHL; 9) DAVINCI PACK WOMENS , Catalog Number: SMAVPDWTMC; 10) PK GYN ROBOTICS OD , Catalog Number: SMA4JGRODB; 11) PK LAPAROSCOPY GYN OD , Catalog Number: SMA4JLGODA
Class IIDeviceOngoing
Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B
Class IIDeviceOngoing
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
Class IIDeviceOngoing
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Sep 9, 2026 · Z-3091-2026

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-3050-2026

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-3053-2026

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-3078-2026

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-3059-2026

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

Reported Sep 9, 2026 · Z-3065-2026

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-3068-2026

A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

Reported Sep 9, 2026 · Z-3066-2026

Fresenius Medical Care Renal Therapies Group, LLC · Waltham, MA

Complaints of blue-green discoloration in product

Reported Sep 9, 2026 · Z-3092-2026

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-3104-2026

Complaints of blue-green discoloration in product

Reported Sep 9, 2026 · Z-3093-2026

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-3100-2026

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-3060-2026

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-3085-2026

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.

Reported Sep 9, 2026 · Z-3070-2026

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-3056-2026

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-3105-2026

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-3061-2026

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-3054-2026

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-3049-2026

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-3041-2026

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-3101-2026

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-3051-2026

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-3048-2026

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.

Reported Sep 9, 2026 · Z-3071-2026

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-3075-2026

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-3069-2026

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-3058-2026

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.

Reported Sep 9, 2026 · Z-3074-2026

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-3097-2026