The Recall Desk

Archive

June 2025 recalls

524 recalls were announced in June 2025.

What the numbers show

Critical
6
Severe
230
High
195
Moderate
85
Low
8

Of the 524 recalls this month scored against our rubric, 1% are Critical, 44% are Severe.

401–500 of 524

  • ModerateFDA (Drugs)·D-0458-2025·2025-06-11

    Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content

    Spectrum Advanced Gel Hand Sanitizer (70% ethyl alcohol, 8 FL OZ) has been recalled nationwide because affected batches contain cloudy appearance and test below the claimed 70% alcohol concentration, making them less effective.

    Product
    HAND SANITIZER — HAND SANITIZER (ETHYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2025·2025-06-11

    FoundationOne Companion Diagnostic F1CDx Incorrect Claim Display

    Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.

    Product
    FoundationOne Companion Diagnostic (F1CDx)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1892-2025·2025-06-11

    BX2 Needle Guide may develop transducer cover breach during attachment

    Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.

    Product
    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1905-2025·2025-06-11

    MIRA Surgical System software update recall for motion display issue

    Virtual Incision Corporation is recalling MIRA Surgical System units with Software Version 4.0.3 due to potential interrupted motion on the surgeon control console display caused by software latency.

    Product
    MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1909-2025·2025-06-11

    Pre-filled Water Syringe recalled for improper use contamination

    Healthmark Industries is recalling Pre-filled Water Syringes (Model SW-010-100 and SW-010) after duodenoscope contamination was linked to improper use of the syringes outside their intended purpose.

    Product
    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0839-2025·2025-06-11

    Sysco Classic and Bay Valley Foods Thank You Chocolate Pudding Recall

    Treehouse Foods is recalling Sysco Classic and Bay Valley Foods Thank You chocolate pudding in 7lb cans due to post-process container damage that could allow microbial growth and cause containers to swell or explode.

    Product
    Sysco Classic chocolate pudding, 7lb #10 metal can, UPC 074865103817, 6 cans per case. Bay Valley Foods Thank You chocolate pudding, 7lb #10 metal can, UPC 041820062205 , 6 cans per case.
    Category
    Food
    Distribution
    15 states
  • LowFDA (Food)·H-0009-2025·2025-06-11

    Best Taste Brand Salted Shrimp Paste Sauce Recalled for Undeclared FD&C Red #3

    Best Taste Brand Salted Shrimp Paste Sauce (12 oz) is recalled because it contains undeclared FD&C Red #3, a food coloring that is not listed on the label.

    Product
    Best Taste Brand Salted Shrimp Paste Sauce; ING: Shrimp, sugar, salt; COUNTRY FAVOR, INC; PRODUCT OF VIETNAM; Net Weight: 12 oz (350 g)
    Category
    Food
    Distribution
    19 states
  • LowFDA (Food)·F-0840-2025·2025-06-11

    Nordic Naturals Zero Sugar Kids Multivitamin Gummies Recall

    Nordic Naturals is recalling Zero Sugar Kids Multivitamin Supplement gummies due to product mislabeling. Consumers should stop using the product and contact the manufacturer with questions.

    Product
    Nordic Naturals Zero Sugar Kids Multivitamin Supplement - Gummies (120 gummies/bottle); 12 bottles/case
    Category
    Consumer Product
    Distribution
    20 states
  • HighNHTSA·25V331000·2025-06-10

    Hyundai Translead Recalls 2026 Dry Van Trailers for Liftgate Pin Defect

    Hyundai Translead is recalling 2026 Dry Van Trailers because insufficient lubrication on the liftgate cylinder pin may cause it to seize, leading to liftgate failure and injury risk.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD DRY VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V364000·2025-06-10

    Forest River trailer side gate latches may unlock during transit

    Forest River is recalling certain 2025 Salem and Wildwood travel trailers because the side entry gate latch may unlock, allowing the strut to open the gate during transit.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V381000·2025-06-09

    Braun Recalls 1,533 Vehicles for Loose Seat Belt Fasteners

    Braun is recalling 1,533 Chrysler Pacifica, Voyager, and Toyota Sienna vehicles because seat belt tie-down fasteners may be loose, increasing injury risk in crashes.

    Product
    BRAUN — BRAUN CHRYSLER PACIFICA, CHRYSLER VOYAGER, TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V332000·2025-06-06

    Volvo Recalls 2025-2026 VN Trucks for Power Cable Routing Defect

    Volvo Trucks North America is recalling 2025-2026 Volvo VN trucks because improperly routed power cables may cause electrical shorts, leading to engine stalls or fires.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V379000·2025-06-06

    Mercedes-Benz GLC 300 and AMG GLC models roof impact protection

    Mercedes-Benz is recalling certain 2023–2025 GLC 300 and GLC 300 4MATIC, 2024–2025 AMG GLC 43 4MATIC, 2025 GLC 350E 4MATIC, and 2025 AMG GLC 63 S E vehicles with panoramic sunroofs. The C-pillar may not absorb adequate impact in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E 4MATIC, GLC 300 4MATIC, AMG GLC63 S E, GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V375000·2025-06-06

    2018–2024 Harley-Davidson Softail motorcycles rear shock issue

    Harley-Davidson is recalling certain 2018–2024 Softail motorcycles because the rear shock pre-load adjuster mounting tab may break and damage the tire, causing sudden loss of pressure and increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXLRS, FLHC, FLHCS ANV, FXLRST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·25316·2025-06-05

    Portable Hook-On Chairs Recalled for Fall Hazard and Serious Injury Risk

    Portable hook-on chairs sold on Amazon by Ravmix pose a fall hazard because the crotch restraint can be removed without tools, allowing infants to fall through. The product violates federal safety standards. Consumers should stop using immediately and contact Ravmix for refund instructions.

    Product
    Portable Hook-On Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25322·2025-06-05

    Apollo America Combination Smoke and Carbon Monoxide Detectors Recalled

    Apollo America 51000-600 combination smoke and carbon monoxide detectors can malfunction and fail to alert users to fire or CO leaks, risking smoke inhalation, CO poisoning, or death. Vivint is sending free replacement detectors to all known purchasers.

    Product
    Apollo America 51000-600 Combination Smoke and Carbon Monoxide Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25311·2025-06-05

    BowFlex Adjustable Dumbbells Recalled Due to Dislodging Weight Plates

    About 3.8 million BowFlex 552 and 1090 adjustable dumbbells are recalled because weight plates can dislodge from the handle during use. Over 100 injuries have been reported, including concussions and broken toes.

    Product
    BowFlex 552, 52.5 LB Adjustable Dumbbells and BowFlex 1090, 90 LB Adjustable Dumbbells
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25318·2025-06-05

    2-in-1 Funlio Convertible Baby High Chairs Recalled for Fall and Entrapment Hazards

    About 380 Funlio convertible high chairs pose entrapment and fall hazards due to violations of federal safety standards. The opening between seat and tray is large enough for a child to become trapped, and the child restraint system can fail.

    Product
    2-in-1 Funlio Convertible Baby High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25315·2025-06-05

    ZHORANGE Portable Bassinets Recalled for Fall Hazard Risk

    ZHORANGE portable bassinets (model 148012-A) are recalled due to sides that are too low and absence of a stand, creating a fall hazard for infants. The product violates federal safety standards for infant sleep products.

    Product
    ZHORANGE Portable Bassinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25326·2025-06-05

    NTI residential gas boilers recalled for fire and carbon monoxide hazards

    NTI Boilers is recalling about 323 NTI-brand TRX Series II residential wall-mounted gas boilers sold in the US because the boiler door can fail to seal properly, posing fire and carbon monoxide poisoning hazards that can result in death or serious injury.

    Product
    NTI residential gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25325·2025-06-05

    HTP residential gas boilers recalled due to fire and carbon monoxide hazard

    HTP-brand ELU Elite Ultra residential gas boilers are being recalled because the boiler door can fail to seal properly, allowing flames and gases to escape, posing fire and carbon monoxide poisoning hazards that can result in death or serious injury.

    Product
    HTP residential gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25312·2025-06-05

    ZRWD Infant Swings Recalled for Suffocation and Battery Hazards

    ZRWD infant swings (model S0008A) sold on Amazon are recalled due to suffocation risk from incline angles exceeding safety limits and missing battery hazard warnings. About 3,540 units are affected.

    Product
    ZRWD Infant Swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V378000·2025-06-05

    Honda CR-V Hybrid fuel feed hose may be improperly installed

    Honda is recalling certain 2025 CR-V Hybrid vehicles because the fuel feed hose may have been improperly installed, allowing fuel to leak. This fails FMVSS 301.

    Product
    HONDA — HONDA CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25324·2025-06-05

    Direct Scaffold Supply Baker Scaffolding Casters Recalled for Fall Hazard

    Direct Scaffold Supply is recalling casters used in multi-purpose baker style scaffolding due to faulty spot welds that can cause caster failure and scaffolding instability, creating a fall hazard. One injury from a caster failure has been reported.

    Product
    Casters on Direct Scaffold Supply Multi-Purpose Baker Style Scaffolding Products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25319·2025-06-05

    Specialized Globe-Branded Haul ST and LT E-Bikes Recalled for Fall Hazard

    Specialized Bicycle Components is recalling about 11,100 Globe-branded Haul ST and LT e-bikes due to a telescopic seat post that can break when fully extended, creating a fall hazard. The company has received 13 incident reports including two minor injuries.

    Product
    Haul ST and LT E-bikes with telescopic seat posts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25314·2025-06-05

    Hobby Toy Hammer Ball Sets Recalled for Choking Hazard Risk

    Hobby Toy Hammer Ball sets sold on Amazon contain small balls that violate federal toy safety regulations for children under three and pose a choking hazard. About 2,000 units sold from September 2024 through April 2025 are affected.

    Product
    Hobby Toy Hammer Ball sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25313·2025-06-05

    Rinnai i-Series Plus Gas Boilers Recalled for Carbon Monoxide Hazard

    Rinnai America is recalling about 2,030 i-Series Plus gas boilers because the door can fail to seal properly due to incorrect screws, allowing carbon monoxide to escape. No injuries have been reported.

    Product
    Rinnai i-Series Plus gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25321·2025-06-05

    Yamaha Golf Car Vehicles Recalled Due to Accelerator Pedal Spring Failure

    Yamaha is expanding a recall of approximately 352,000 golf car vehicles because the accelerator pedal spring can fail to return to idle, posing a crash hazard. No injuries have been reported to date.

    Product
    Yamaha Golf Car Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V366000·2025-06-05

    Mercedes-Benz EQE and EQS vehicles recalled for defective pedestrian alert software

    Mercedes-Benz is recalling certain 2022–2025 S-Class, EQE, EQE SUV, EQS, and EQS SUV vehicles because the Acoustic Vehicle Alerting System (AVAS) software may produce an incorrect warning sound while reversing, potentially failing to alert pedestrians.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH EQS 450+, EQS 580 4MATIC, EQS SUV 580 4MATIC, EQS SUV 450 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25323·2025-06-05

    DR Power Equipment Battery-Powered Chainsaws Recalled for Fire and Burn Hazards

    DR Power Equipment battery-powered chainsaws are being recalled because the motor controller can overheat during operation, posing fire and burn hazards. About 7,180 units were distributed nationwide.

    Product
    Battery-Powered Chainsaws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25320·2025-06-05

    Midea Recalls 1.7 Million U and U+ Window Air Conditioners Due to Mold Exposure Risk

    Midea is recalling about 1.7 million U and U+ Window Air Conditioners because pooled water can fail to drain quickly, allowing mold to grow. At least 152 mold reports exist, including 17 reports of consumers experiencing respiratory infections, allergic reactions, coughing, sneezing, and sore throats.

    Product
    U and U+ Window Air Conditioners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·25317·2025-06-05

    Lutron Power Interfaces for LED Tape Lights Recalled for Shock Hazard

    Lutron-branded power interfaces for LED tape lights can fail during power surges like lightning strikes, creating a shock hazard. About 1,944 units are affected; no injuries have been reported.

    Product
    Lutron-branded power interfaces for LED tape lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1818-2025·2025-06-04

    ELEOS Collar Stem 15mm mistakenly labeled as 13mm modular stem

    Onkos Surgical is recalling ELEOS Collar Stem components (Model HC-15120-03M) that were packaged and labeled as 13mm modular segmental stems when they are actually 15mm in diameter. This mislabeling could result in implantation of an incorrectly-sized component during limb salvage surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V374000·2025-06-04

    Triple E Recalls 2025 Motorhomes Due to Wiring Insulation Defect

    Triple E is recalling 2025 Wonder and Unity motorhomes because incorrectly installed inverter wiring insulation may overheat, increasing the risk of fire.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0822-2025·2025-06-04

    Tomato 3 Count recalled due to potential Salmonella contamination

    Williams Farms Produce Sales Co., Inc. is recalling Tomato 3 Count products (UPC 0 33383 65504 8) distributed to GA, NC, and SC because the product may contain Salmonella.

    Product
    Tomato 3 Count UPC 0 33383 65504 8, 10lb box, 25lb box & 60ct/2 layer box Williams Farms Repack, LLC Lodge, SC 29082
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2025·2025-06-04

    Carvedilol Tablets Recalled Due to N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2025·2025-06-04

    Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2025·2025-06-04

    Endurance Boost With Horny Goat Weed Supplement Recalled for Undisclosed Drug Content

    VEPEMVA Nutrition's Endurance Boost with Horny Goat Weed has been recalled because it contains Sildenafil and Propoxyphenylsildenafil, undisclosed active pharmaceutical ingredients. The product was marketed and sold without FDA approval.

    Product
    ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit

    Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2025·2025-06-04

    Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2025·2025-06-04

    ELEOS Male-Female Midsection 40MM Orthopedic Component Recall

    Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.

    Product
    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2025·2025-06-04

    Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires

    Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 units distributed worldwide.

    Product
    Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2025·2025-06-04

    Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion

    Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2025·2025-06-04

    GM Helix Acqua Implant dental implant size misidentification recall

    Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0813-2025·2025-06-04

    Hummingbird Organic Roasted Salted Cashews recalled for undeclared hazelnut

    Honey Heaven Wholesale Inc is recalling 6-oz bags of Hummingbird Organic Roasted Salted Cashews because the product contains hazelnut but the label does not declare it, creating a hazard for consumers with hazelnut allergies.

    Product
    Kraft package is labeled as Hummingbird Organic Roasted Salted Cashews, net wt. 6oz.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0811-2025·2025-06-04

    Mauna Loa Dark Chocolate Covered Macadamias Recalled for Undeclared Nuts

    Hawaiian Host Candies is recalling Mauna Loa Dark Chocolate Covered Macadamias due to undeclared almond and cashew. The product label does not list these allergens and may pose a risk to consumers with tree nut allergies.

    Product
    Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic flexible pouch. Dist. By Mauna Loa Macadamia Nut Corp. Kea au, Hawaii 96749, USA. Label declares Contains: Tree Nuts (Macadamia), Milk and Soy. Each master case contains
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1860-2025·2025-06-04

    DORO Easy-Connect Navigation Adaptor compatibility issue recall

    Pro-Med Instruments is recalling the DORO Easy-Connect Navigation Adaptor due to potential compatibility problems that could affect positioning accuracy and navigation system function. The company distributed 217 units worldwide.

    Product
    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2025·2025-06-04

    Segmental Stem Components for ELEOS Limb Salvage System Recalled

    Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.

    Product
    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1877-2025·2025-06-04

    BioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 plus Kit (Lot# 1475424) due to a manufacturing error that may cause elevated control failures and false negative test results.

    Product
    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1823-2025·2025-06-04

    Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall

    The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.

    Product
    Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·25V324000·2025-06-04

    2025 Nissan Frontier rear display may blank in reverse

    The 2025 Nissan Frontier's center information display may show a blank screen in reverse, violating federal rear-visibility standards. This could reduce driver visibility and increase crash risk.

    Product
    NISSAN — NISSAN FRONTIER, KICKS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V376000·2025-06-04

    Kawasaki Ninja ZX-6R Motorcycles Engine Crankshaft Bushing Recall

    Kawasaki is recalling certain 2024–2025 Ninja ZX-6R motorcycles because the engine may lose power during operation due to crankshaft bushing seizure, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA ZX-6R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2025·2025-06-04

    Abbott Diagnostics Vitamin D Calibrator Transit Storage Conditions Issue

    The Abbott Diagnostics Architect Vitamin D 6-Level Calibrator was exposed to improper storage conditions during transit due to severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2025·2025-06-04

    NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk

    NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.

    Product
    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2025·2025-06-04

    Ortho Clinical Diagnostics Vancomycin Reagent Cold Chain Recall

    Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Vancomycin reagent (Catalog No. 6801709) distributed nationwide due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2025·2025-06-04

    Cholestech LDX Lipid Profile and Glucose Test Kits Recalled

    McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall

    Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2025·2025-06-04

    Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach

    Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.

    Product
    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1849-2025·2025-06-04

    Abbott Diagnostics Architect Total T36X4ML Calibrator Cold Chain Excursion

    Abbott Diagnostics Architect Total T36X4ML Calibrator units experienced transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

    Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2025·2025-06-04

    Abbott Diagnostics Architect Free T4 Calibrator Recall

    Abbott Diagnostics Architect Free T4 Calibrator units may have been exposed to improper storage conditions due to transit delays from severe thunderstorms, potentially causing incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Triple Lumen Recall

    Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter recalled for sterility defect

    Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2025·2025-06-04

    HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions

    HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2025·2025-06-04

    Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion

    Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2025·2025-06-04

    Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue

    Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2025·2025-06-04

    Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled

    Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2025·2025-06-04

    BD Microbiology MacConkey II Agar Media Storage Condition Recall

    BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2025·2025-06-04

    Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall

    Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2025·2025-06-04

    Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions

    Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.

    Product
    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide

    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2025·2025-06-04

    Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications

    Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.

    Product
    BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1821-2025·2025-06-04

    Atellica IM Homocysteine Calibrator recalled for assay instability

    Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.

    Product
    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2025·2025-06-04

    HemoCue Inc Hemotrol Low Control affected by cold chain transit delays

    HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2025·2025-06-04

    HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions

    HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.

    Product
    HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2025·2025-06-04

    Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

    C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

    Product
    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2025·2025-06-04

    Siemens ADVIA Centaur HCY Calibrator packs recalled for calibrator instability

    Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.

    Product
    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2025·2025-06-04

    Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure

    Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2025·2025-06-04

    Abbott Diagnostics Probe Conditioning Solution Recall

    Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2025·2025-06-04

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in incorrect or delayed test results.

    Product
    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2025·2025-06-04

    Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure

    Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2025·2025-06-04

    Theophylline Extended-Release Tablets recalled for dissolution test failure

    Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2025·2025-06-04

    Segmental Stem Bowed 152MM components recall potential seal breach

    Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.

    Product
    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1846-2025·2025-06-04

    Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure

    McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2025·2025-06-04

    Ortho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall

    Mckesson Medical-Surgical is recalling Ortho Clinical Diagnostics Total Bili-Alkp XT (L-Sequester) reagent due to cold chain storage failures during transit caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall

    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2025·2025-06-04

    Male-Female Midsection components from ELEOS Segmental Limb Salvage System

    Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.

    Product
    Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Mal
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1847-2025·2025-06-04

    Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure

    Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2025·2025-06-04

    Segmental Stem Components Recalled for Potential Tyvek Seal Breach

    Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.

    Product
    Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1828-2025·2025-06-04

    BD Microbiology Fluid Thioglycollate Medium Tubes Recall

    McKessan Medical-Surgical is recalling BD Microbiology Fluid Thioglycollate Medium tubes due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1825-2025·2025-06-04

    Abbott Rapid DX Cholestec LDX Lipid Profile Test Cassettes Recall

    Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1859-2025·2025-06-04

    Ultrasonic Cleaning Systems Triton 36 and 72 recalled

    Ultra Clean Systems, Inc. is recalling Ultrasonic Cleaning Systems Triton 36 and Triton 72 models due to carbon filter sensors breaking down from electrochemical degradation. The defect was identified during routine preventative maintenance checks.

    Product
    Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
    Category
    Medical Device
    Distribution
    Distributed nationwide

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