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Page 36 of 40Severity
FlexLab (FLX); Version: FLX-217-10;The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.
FDADec 3, 2025Inpeco2 products
- CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
FDADec 3, 2025
- Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional t
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
FDADec 3, 2025Argon Medical Devices
- Quantum heated massage tables recalled for overheating risk
Pivotal Health Solutions is recalling 2 Quantum Intersegmental Table models with heated massage functions. The heat function can become damaged over time when patients press on the heated areas, which can lead to overheating, smoldering, and melting of the vinyl cushion. No injuries have been reported.
ModerateFDADec 3, 20252 products
- 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Products may contain contamination, which may result in a darker or brown media color.
FDADec 3, 2025
- The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
FDADec 3, 2025Magellan Diagnostics
- DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
FDADec 3, 2025DermaSensor
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDADec 3, 2025
- Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
FDADec 3, 2025
- Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
FDADec 3, 2025
- Foundation Medicine FoundationOne CDx tests recalled for missing claims pages
Foundation Medicine sent some test reports to customers without the companion diagnostic (CDx) Claims Page. The missing pages were sent later in amended reports, within 7 days of the issue. This recall covers 2 products, FoundationOne CDx and FoundationOne Liquid CDx, with 77 affected units total.
ModerateFDADec 3, 20252 products
- Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
FDADec 3, 2025
- SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
The impacted lot may not meet the required tensile strength specification.
FDADec 3, 2025Glycar2 products
Member's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775Potential contamination of Salmonella Richmond
FDADec 3, 2025
CA Botana skin products recalled for manufacturing issuesCA Botana is recalling 14 skin care products, including mineral sunscreens, tinted moisturizers, acne creams, and pain relief gels. The products were sold under several brands, including Doctor D. Schwab, Gabriel, Karina, Sugared+Bronzed, Elixir by Coco March, CLEARSTEM, Dr. Bump, and Sea Enzyme. The recall covers manufacturing that did not meet FDA quality standards, and it applies to products distributed in CA, CO, FL, PR, and WA. No injuries have been reported.
ModerateFDADec 3, 2025CA Botana14 products
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDADec 3, 2025
- Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
FDADec 3, 2025Medical Products Laboratories
- ACUSON and Sterilmed catheters recalled for sterility risk
Sterilmed is recalling two reprocessed catheter products because they were reprocessed beyond validated cycles. This may compromise the device's sterility or mechanical integrity and could lead to infection, vascular injury, or embolism. No injuries have been reported, and the recall covers distribution in Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, and Utah.
ModerateFDANov 26, 2025Sterilmed2 products
- Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
FDANov 26, 2025
- Meridian alethia tests recalled for possible buffer leakage
Meridian Bioscience is recalling 2 alethia test kits, the C. difficile and Group B Streptococcus assays, both listed under catalog number 480050. The reaction buffer tube cap may be missing its black rubber gasket, which could cause leakage and reduced buffer volume. No injuries have been reported.
ModerateFDANov 26, 2025Meridian Bioscience2 products
- SAFE-T-FILL blood collection tubes recalled for unvalidated manufacturing
Anatomy Supply Partners is recalling 24 SAFE-T-FILL blood collection products, including capillary tubes, blood gas tubes, end caps, magnetic rings, mixing fleas, and a tube extender. The products were made under an inadequate quality system that used manufacturing processes that had not been validated. The products were distributed nationwide in the US and in Canada, and no injuries have been reported.
ModerateFDANov 26, 2025Anatomy Supply Partners24 products
- MONARCH Bronchoscope. Model Number: MBR-000211-B
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
FDANov 26, 2025Auris Health
- REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
FDANov 26, 2025Cellavision
- DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
FDANov 26, 2025
- Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
Due to incorrect product label (Incorrect product name identified on outer packaging).
FDANov 26, 2025Berkeley Advanced Biomaterials
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
FDANov 26, 2025
- OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
FDANov 26, 2025Polymedco
- Exactech Equinoxe Ergo surgical instruments recalled for untested design
Exactech is recalling three Equinoxe Ergo surgical instruments used in shoulder replacement procedures. The products were released before completing design updates and performance testing, so they may not meet required design and performance criteria. No injuries have been reported.
ModerateFDANov 26, 2025Exactech3 products
- Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component
Due to distributing the measles IgG IVD without a premarket approved/cleared.
FDANov 26, 2025Quest
- PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
FDANov 26, 2025