The Recall Desk

Archive

July 2024 recalls

547 recalls were announced in July 2024.

What the numbers show

Critical
9
Severe
88
High
398
Moderate
49
Low
3

Of the 547 recalls this month scored against our rubric, 2% are Critical, 16% are Severe.

201–300 of 547

  • SevereCPSC·24307·2024-07-18

    CFMOTO ZFORCE 950 ROVs Recalled for Crash and Tip-Over Hazards

    CFMOTO is recalling approximately 3,630 ZFORCE 950 HO Sport Side-by-Side recreational off-highway vehicles from 2022–2023 because the shock absorber rod assembly can unthread and detach, causing suspension collapse and crash or tip-over hazards.

    Product
    CFMOTO ZFORCE 950 HO Sport Side-by-Side ROVs (2022-2023)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V540000·2024-07-18

    2024 Honda Prologue Front Suspension Control Arm Fracture Recall

    Honda is recalling 2024 Prologue vehicles because the right front lower control arm may contain a manufacturing defect that can fracture, causing loss of vehicle control and increasing crash risk.

    Product
    HONDA — HONDA PROLOGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24308·2024-07-18

    Manhattan Toy Brilliant Bee Rattles Recalled for Choking Hazard

    Sassy Baby Inc. is recalling about 3,000 Manhattan Toy Brilliant Bee Rattles because the wooden base can detach and release plastic rings that pose a choking hazard to young children.

    Product
    Brilliant Bee Rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24309·2024-07-18

    BISSELL Steam Shot Handheld Steam Cleaners Recalled for Burn Hazard

    BISSELL is recalling about 3.2 million Steam Shot Handheld Steam Cleaners because they can expel hot water or steam during heating or use, causing burn injuries. The company has received 183 reports of hot water or steam escaping, including 157 reports of minor burn injuries.

    Product
    BISSELL® Steam Shot™ Handheld Steam Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V541000·2024-07-18

    2021–2025 Winnebago Ekko Motorhomes Solar Charging System Fuse Melt Risk

    Winnebago is recalling 2021–2025 Ekko motorhomes due to inadequate over-current protection in the solar charging system, which can cause the fuse to melt and increase fire risk. Dealers will replace the solar controller fuse and related components at no charge.

    Product
    WINNEBAGO — WINNEBAGO EKKO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2252-2024·2024-07-17

    Medical Device Recall: Bausch+Lomb Intravitreal Injection Kit Unvalidated Sterilization

    Synergetics Inc is recalling Bausch+Lomb I-PACK Intravitreal Injection Kits because sterilization certificates could not be validated by the supplier. The FDA classified this as Class I.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1464-2024·2024-07-17

    Crecelac Infant Powdered Formula Recalled Due to Cronobacter

    Dairy Manufacturers' Crecelac Infant formula (5,376 cans distributed in Texas) is recalled due to Cronobacter spp. detected during FDA testing. Products lack required premarket evaluation for food safety and nutritional standards.

    Product
    Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1467-2024·2024-07-17

    7-Eleven Chicken Salad Sandwich Recalled for Undeclared Milk Allergen

    Taylor Farms Northwest recalled 7-Eleven Simply Chicken Salad Sandwiches for containing undeclared milk. The Class I recall affects 319 units distributed in Oregon and Washington.

    Product
    7-Eleven Simply Chicken Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.6oz (187g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1468-2024·2024-07-17

    7-Eleven Simply Egg Salad Sandwich recalled due to undeclared milk allergen

    Taylor Farms Northwest LLC has voluntarily recalled 7-Eleven Simply Egg Salad Sandwich (6.8 oz) due to undeclared milk, affecting products distributed in Oregon and Washington.

    Product
    7-Eleven Simply Egg Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.8oz (193g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1473-2024·2024-07-17

    Leona's Ice Cream Sandwiches Recalled for Peanut Cross-Contamination

    Leona's Strawberry Pretzel Salad ice cream sandwiches are recalled due to peanut cross-contamination. The product was distributed in Pennsylvania.

    Product
    Leona's Ice Cream , Strawberry Pretzel Salad, Individually wrapped, 6 oz. sandwich
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0588-2024·2024-07-17

    OTC Sunscreen Foundation Recalled for Fungal Mold Contamination

    Suntegrity IMPECCABLE SKIN sunscreen foundation is recalled for microbial contamination with Aspergillus Sydowii mold. Consumers should discontinue use immediately.

    Product
    IMPECCABLE SKIN - IVORY — IMPECCABLE SKIN - IVORY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1472-2024·2024-07-17

    Arepas La Mejor Arepa de Chocolo Recalled for Undeclared Milk Allergen

    Villa Nueva Interservices is recalling Arepas La Mejor Arepa de Chocolo due to undeclared milk allergen. Consumers with milk allergies are at risk.

    Product
    Arepas La Mejor, Arepa de Chocolo (Chocolate Sweet Corn Pancakes), NET WT. 25 Oz., 5 units per package, KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2315-2024·2024-07-17

    Baxter iLED 7 surgical lights recalled due to thermal burn risk

    Baxter Healthcare is recalling iLED 7 surgical lights due to customer reports of thermal skin injuries. The recall affects approximately 6,243 units distributed worldwide.

    Product
    iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2254-2024·2024-07-17

    Intravitreal Injection Kit Recalled for Unvalidated Sterilization Certificates

    Synergetics Inc is recalling 35 units of the BAUSCH+LOMB I-PACK Intravitreal Injection Kit because sterilization certificates could not be validated, creating an infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1466-2024·2024-07-17

    Queso Rico La Hacienda Queso Fresco Cheese Recalled for Listeria

    Queso Rico La Hacienda brand queso fresco cheese was found to contain Listeria monocytogenes. FDA Class I recall affects 640 pounds distributed to retail stores in Texas counties.

    Product
    Queso Rico La Hacienda brand queso fresco cheese packaged in 9 oz, 1 pound, and 2 pound plastic packages. Product labeling reads in part "***QUESO RICO LA HACIENDA***EL QUESO FRESCO FRESCO DE VERACRUZ***Lic. Permit #483709 El Queso Rico "LA HACIENDA"***5617 E. Trenton Rd., Suite
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1463-2024·2024-07-17

    Powdered infant formula recalled for missing safety evaluation

    Farmalac powdered infant formula was recalled because the manufacturer failed to submit required premarket notification to the FDA. The product was never evaluated for safety or nutritional standards.

    Product
    Farmalac powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2253-2024·2024-07-17

    BAUSCH+LOMB I-PACK Injection Kit Recalled Due to Sterilization Validation Failure

    FDA has recalled 116 units of BAUSCH+LOMB I-PACK Injection Kits because sterilization certificates could not be validated by the supplier, creating potential infection risk for patients receiving intravitreal eye injections.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1465-2024·2024-07-17

    Infant Formula Recalled for Lack of Premarket Safety Evaluation

    Farmalac 0-12 Low lactose powdered infant formula is being recalled because the manufacturer did not submit required premarket notification to the FDA. The product has not been evaluated against U.S. food safety and nutritional standards.

    Product
    Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz cans
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2314-2024·2024-07-17

    Baxter Trulight Surgical Lights Recalled for Thermal Skin Injuries

    Baxter Healthcare Corporation recalled Trulight 5000/3000 Surgical Light systems due to customer reports of thermal skin injuries. The urgent medical device correction affects models 4038210 and 4038310 distributed worldwide.

    Product
    Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2251-2024·2024-07-17

    Bausch+Lomb I-PACK Injection Kit Recalled for Unvalidated Sterilization

    Synergetics Inc is recalling the Bausch+Lomb I-PACK Injection Kit nationwide because sterilization certificates could not be validated by the supplier. The unvalidated sterilization of this eye injection device poses a potential infection risk.

    Product
    BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2313-2024·2024-07-17

    Baxter VidiaPort and Trulight surgical lights recalled for thermal burn risk

    Baxter Healthcare Corporation is recalling VidiaPort and Trulight surgical light systems due to customer reports of thermal skin injuries. Approximately 275 units were distributed worldwide.

    Product
    VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2304-2024·2024-07-17

    Arthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue

    American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.

    Product
    ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2024·2024-07-17

    Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue

    American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.

    Product
    FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2024·2024-07-17

    Presource surgical kits recalled for syringe design defect risk

    Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.

    Product
    Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0590-2024·2024-07-17

    Bupropion Extended-Release Tablets Recalled for Dissolution Failure

    Amerisource Health Services is recalling Bupropion Hydrochloride 150mg extended-release tablets nationwide due to dissolution specification failures. The tablets dissolve faster than specified limits.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2024·2024-07-17

    TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals

    American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2024·2024-07-17

    Compounded Lidocaine-Epinephrine Injectable Recalled Nationwide for Subpotent Epinephrine

    Tailstorm Health Inc is recalling a compounded lidocaine-epinephrine injection nationwide due to subpotent epinephrine component. The recall affects 12,525 vials of lot number 2311003.

    Product
    Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V535000·2024-07-17

    2023–2024 Suzuki DL800 Motorcycle Rear Tire Tread Separation

    Suzuki is recalling certain 2023–2024 DL800 motorcycles because the rear tire may crack or deform, causing tread separation and loss of vehicle control. Owners should not ride the motorcycle until the rear tire is replaced.

    Product
    SUZUKI — SUZUKI DL800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2024·2024-07-17

    Upper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals

    American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.

    Product
    UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2337-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for Altered Component Spacing

    Maquet Cardiovascular is recalling 600 units of the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System due to reports of C-Ring wire straightening and altered spacing between components. No adverse events have been reported.

    Product
    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2024·2024-07-17

    ALPHAMAXX Operating Table Defective Charger Recalled for Operational Failure Risk

    Getinge Usa Sales Inc recalls 73 ALPHAMAXX mobile operating tables due to a defective charger unit that poses a risk of inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2280-2024·2024-07-17

    Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue

    American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.

    Product
    ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2024·2024-07-17

    Blood Pump Rotor Spare Part Recall Due to Loose Guide Sheaves

    Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.

    Product
    RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2024·2024-07-17

    Welch Allyn CP150 Electrocardiograph recalled for missing electromagnetic interference absorber

    Baxter Healthcare is recalling the Welch Allyn CP150 Electrocardiograph because a critical manufacturing step—installation of an electromagnetic interference absorber—was omitted. This could cause device malfunction or interference with nearby medical equipment.

    Product
    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2311-2024·2024-07-17

    Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2024·2024-07-17

    Surgical Knee Arthroscopy Kit Recalled for Excessive Sterilization Gas Residuals

    American Contract Systems Inc is recalling its KNEE ARTHROSCOPY-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent medical devices. The recall affects 28 units with lot numbers 975241 and 920241.

    Product
    KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2024·2024-07-17

    Medical examination gloves recalled for skin irritation and disintegration

    SVS LLC is recalling 155,540 boxes of non-sterile nitrile examination gloves due to reported skin irritation, glove disintegration with certain cleaning solutions, and size mislabeling. Gloves were distributed nationwide across eight U.S. states.

    Product
    Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes inc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2024·2024-07-17

    Knee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue

    American Contract Systems Inc is recalling 36 units of its knee arthroscopy procedure kit due to excessive sterilization chemical residues in the cast padding component that exceed safe exposure limits.

    Product
    KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2347-2024·2024-07-17

    Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

    Product
    RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2024·2024-07-17

    TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.

    Product
    TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2024·2024-07-17

    GE Vivid Ultrasound Scanner Displays Incorrect Patient Data

    GE Vivid ultrasound systems may display incorrect patient names and demographics due to slow DICOM response times, risking patient misidentification during imaging.

    Product
    GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2290-2024·2024-07-17

    Total knee prosthesis recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling 272 units of its TOTAL KNEE prosthesis nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe limits for permanent implants.

    Product
    TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2024·2024-07-17

    Orthopedic knee procedure tray recalled for sterilization residue levels

    American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.

    Product
    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2286-2024·2024-07-17

    Procedure Tray Recalled Due to Excess Sterilization Residue

    American Contract Systems Inc is recalling HAND WRIST FOREARM-LF Procedure trays due to ethylene oxide sterilization residues exceeding safe limits for permanent exposure devices.

    Product
    HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2278-2024·2024-07-17

    Knee surgery procedure tray recalled for chemical contamination

    American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01AA) due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed acceptable regulatory limits.

    Product
    TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2024·2024-07-17

    Knee Procedure Kit Recalled Due to Ethylene Oxide Residual Contamination

    American Contract Systems Inc recalls 174 units of CUSTOM KNEE procedure kits due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe exposure limits for permanent contact devices.

    Product
    CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2024·2024-07-17

    ZOLL Powerheart G5 AED shipping film may prevent shock delivery

    ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.

    Product
    ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2024·2024-07-17

    Medical Device Procedure Tray Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack procedure tray because sterilant residues (ethylene oxide and ethylene chlorohydrin) exceed safe limits for permanent-use medical devices.

    Product
    BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2024·2024-07-17

    Procedure Tray Recalled for Excessive Ethylene Oxide Residuals

    American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical devices.

    Product
    ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2024·2024-07-17

    Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination

    American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory limits for permanent-contact medical devices.

    Product
    ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2024·2024-07-17

    Knee Arthroscopy Pack Recalled for Excess Sterilization Residues

    American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2024·2024-07-17

    Medical Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling Synergetics I-Pack Injection Kits because some units may not have been properly sterilized, potentially causing post-operative wound or injection site infections.

    Product
    Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2307-2024·2024-07-17

    CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals

    American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.

    Product
    CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2024·2024-07-17

    Ophthalmic Injection Kit Recall Due to Unconfirmed Sterilization

    MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.

    Product
    Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2345-2024·2024-07-17

    Hemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves

    Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.

    Product
    RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2316-2024·2024-07-17

    GE Vivid Ultrasound Systems Display Incorrect Patient Names

    GE Vivid ultrasound systems may display incorrect patient information due to slow DICOM response times. Seven affected units were distributed to healthcare facilities in IL, MA, NM, NY, and OK.

    Product
    GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2346-2024·2024-07-17

    Hemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves

    Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.

    Product
    RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues

    American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.

    Product
    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2024·2024-07-17

    Orthopedic ORIF Hip Rod Procedure Kit Recalled for Sterilization Residuals

    American Contract Systems Inc is recalling its ORIF HIP IM RODDING FEMUR-Procedure Kit (28 units) because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe limits for permanent implants.

    Product
    ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue

    American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.

    Product
    TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2024·2024-07-17

    Ophthalmic injection kit recalled over sterilization confirmation failure

    MICROspecialties recalls 780 units of the Synergetics I Pack Injection Kit (Model 18069) because the company could not confirm proper sterilization, creating risk of post-operative or injection-site infections.

    Product
    Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1469-2024·2024-07-17

    Gluten Free Cookies Recalled for Missing Ingredient Statement on Label

    C. Krueger Finest Baked Goods is recalling 3,347 Gluten Free White Chocolate Cherry Oatmeal Cookies due to missing ingredient statements on labels, preventing consumers from identifying allergens and dietary content.

    Product
    C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-2325-2024·2024-07-17

    Kosmos iOS Ultrasound Software Update Due to Measurement Accuracy Bug

    Echonous Inc is recalling Kosmos ultrasound software for iOS due to a bug causing inaccurate measurements in DICOM exports, potentially leading to incorrect diagnoses.

    Product
    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Food)·F-1470-2024·2024-07-17

    C. Kreuger Gluten Free Peanut Butter Cookies recalled for missing ingredient statement

    C. Krueger Finest Baked Goods is recalling C. Kreuger Gluten Free Peanut Butter Cookies due to missing ingredient statement on labels, preventing consumers from identifying allergens. The recall affects 4,538 cookies distributed across all U.S. states.

    Product
    C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-2272-2024·2024-07-17

    Mobile Operating Table Charger Defect Poses Risk of Operational Failure

    Getinge USA Sales Inc is recalling 171 ALPHAMAXX mobile operating table units due to a defective charger unit that may cause inadequate charging and operational failure.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2326-2024·2024-07-17

    Decompression Table Model E9011 Recalled for Structural Frame Defect

    Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.

    Product
    Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2276-2024·2024-07-17

    American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals

    American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.

    Product
    MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2024·2024-07-17

    Knee Procedure Kit Recalled for Elevated Chemical Residuals

    American Contract Systems Inc is recalling 26 TOTAL KNEE Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residues on the cast padding component that exceed safe exposure limits.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1474-2024·2024-07-17

    Hudson Harvest Tomato Basil Sauce Recalled Due to Under-Processing

    Hudson Harvest Tomato Basil Sauce may be under-processed, creating a potential food safety risk. The recall affects 243 jars with lot #1042426 distributed in New York, Massachusetts, and Connecticut.

    Product
    Hudson Harvest Tomato Basil Sauce, 16 oz., UPC # 683720301567
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2024·2024-07-17

    AURORA Surgiscope System Recalled for Potential Sheath Damage

    Integra LifeSciences is recalling 14 units of the AURORA Surgiscope System due to potential sheath damage that could cause tissue damage or internal bleeding.

    Product
    AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2329-2024·2024-07-17

    Cardiovascular Procedure Kits Recalled for Potential Syringe Design Defects

    Cardinal Health recalls 17,445 cardiovascular procedure kits nationwide containing potentially defective syringes that could cause inaccurate dosing or device leakage.

    Product
    Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2024·2024-07-17

    Blood Pump Rotor for Hemodialysis System Recalled for Loose Components

    Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.

    Product
    190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2024·2024-07-17

    Cast Padding Component Recalled for Excess Ethylene Oxide Residuals

    American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.

    Product
    ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2281-2024·2024-07-17

    Arthroscopy Procedure Tray Recalled for Sterilant Residual Contamination

    American Contract Systems Inc is recalling 272 units of the ARTHROSCOPY SUP JOI PACK Procedure Tray because sterilant residuals in the cast padding exceeded safe limits for permanent implant use.

    Product
    ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2273-2024·2024-07-17

    ALPHAMAXX Mobile Operating Table Charger Defect Poses Equipment Failure Risk

    Getinge has recalled 7 ALPHAMAXX mobile operating tables due to a defective charger unit that may not charge properly, risking equipment operational failure during use.

    Product
    ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2318-2024·2024-07-17

    Dental abutment recall due to incorrect product packaging and labeling

    Preat Corp recalled 7 units of 9006767 Astra EV 4.8mm Milled Titanium Abutments due to incorrect products being packaged and labeled. Affected units were distributed in California, Missouri, and Nevada.

    Product
    9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0587-2024·2024-07-17

    Dianeal Low Calcium Dialysis Solution Recall: Sterility Risk from Connector Leaks

    Baxter Healthcare recalls 6,874 bags of Dianeal Low Calcium peritoneal dialysis solution due to potential leaks in the connector assembly that could compromise product sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2024·2024-07-17

    Arthroscopy Kit Recalled for Excessive Sterilant Residue on Padding

    American Contract Systems is recalling 27 arthroscopy procedure kits because the cast padding component contains ethylene oxide and ethylene chlorohydrin residues exceeding safe limits for permanent exposure devices.

    Product
    ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2024·2024-07-17

    Procedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding

    American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory limits.

    Product
    HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2024·2024-07-17

    Hand Draping Surgical Kit Recalled for Ethylene Oxide Residue

    American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit because residual levels of ethylene oxide and ethylene chlorohydrin exceeded safe limits for permanent-contact medical devices.

    Product
    HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2024·2024-07-17

    Medical knee procedure kit recalled for excessive sterilization chemical residue

    American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2024·2024-07-17

    Hand Procedure Kit Recalled for Excess Ethylene Oxide Residuals

    American Contract Systems recalls HAND PACK-Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residuals on the cast padding component, exceeding safe permanent-contact exposure limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2024·2024-07-17

    Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening

    Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.

    Product
    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2024·2024-07-17

    Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect

    Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.

    Product
    Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2024·2024-07-17

    Ophthalmic injection kit recalled due to sterilization process verification failure

    MICROspecialties is recalling 804 units of the Synergetics I Pack Injection Kit due to inability to confirm proper sterilization, which could lead to post-operative wound infections or injection site infections.

    Product
    Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2287-2024·2024-07-17

    Knee Scope Procedure Tray Recalled for Excess Sterilization Residue Levels

    American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits because ethylene oxide sterilization residues in the cast padding component exceed safe exposure limits per FDA and ISO standards.

    Product
    KNEE SCOPE Procedure tray Catalog Number: COKN48L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2024·2024-07-17

    Blood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System

    Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.

    Product
    190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2024·2024-07-17

    Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

    Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.

    Product
    190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1475-2024·2024-07-17

    Food recall: Bakeshop muffins contain undeclared walnut allergen

    Bakeshop Chocolate Chip Muffins sold at ALDI stores nationwide are being recalled because they contain undeclared walnut, a common allergen. Consumers with walnut allergies should not consume the product.

    Product
    Bakeshop Chocolate Chip Muffin 4 count, in clear plastic clamshell, UPC 4099100048278. 5 retail units per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2024·2024-07-17

    Arthroscopy Pack Recalled for Excessive Sterilization Chemical Residue

    American Contract Systems is recalling 345 units of the AHAR50K Standard Arthroscopy Pack due to ethylene oxide residue levels exceeding regulatory limits. Affected lot numbers are 638231, 962241, and 898241.

    Product
    AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2024·2024-07-17

    Presource Neurological Surgical Kits Recalled for Syringe Design Defect

    Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.

    Product
    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2339-2024·2024-07-17

    Braun Thermoscan PRO 6000 Recall: Outdated Instructions on Included CD

    Braun Thermoscan PRO 6000 ear thermometers may have been shipped with outdated Instructions for Use on an included CD. Approximately 265,647 units were distributed globally.

    Product
    Braun Thermoscan¿ PRO 6000 Ear Thermometer
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2269-2024·2024-07-17

    Breast transilluminator recalled due to lack of FDA premarket approval

    Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.

    Product
    Pink Luminous Breast, Breast transilluminator
    Category
    Medical Device
    Distribution
    Distributed nationwide

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