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Page 37 of 40Severity
Medline kits containing SafeAir pencils recalled for activation riskMedline is recalling 20 kit products that contain SafeAir Smoke Evacuation Pencils made by Stryker Instruments. The recall was expanded to add 47 more pencil lots to an October 2024 recall, because the pencils may activate without manual input when plugged into a power source, or stay active after the buttons are released. No injuries have been reported.
ModerateFDANov 26, 202520 products
- MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
FDANov 26, 2025
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
FDANov 26, 2025
- HeartMate LVAD controllers recalled for backup battery corrosion
Thoratec, a HeartMate company, is recalling four HeartMate heart pump system products because the backup battery cable connector may corrode. This can trigger a Backup Battery Fault alarm. No injuries have been reported.
ModerateFDANov 26, 20254 products
- BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
FDANov 26, 2025
- TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
FDANov 26, 2025TMJ Solutions
- BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
FDANov 26, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
FDANov 26, 20252 products
- Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
FDANov 26, 2025Park Avenue Compounding
- DermaRite skin and sanitizer products recalled for contamination
DermaRite Industries is recalling 18 skin care, antiseptic, hand sanitizer, and antiperspirant products sold nationwide, including the McKesson Skin Protectant distributed by McKesson. The recall was filed because of manufacturing quality problems, and other products and lots made at the same facility were found to be contaminated. No injuries have been reported.
ModerateFDANov 26, 2025DermaRite18 products
- Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
FDANov 26, 2025
- NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
Failed Dissolution Specifications
FDANov 26, 2025
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDANov 26, 2025
- Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
FDANov 19, 2025Techno-Path Manufacturing2 products
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Due to an device without a premarket clearance being incorrectly package and distributed.
FDANov 19, 2025
- Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and di
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
FDANov 19, 2025Shimadzu
- Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I
The nasal feeding tube may be occluded
FDANov 19, 2025Applied Medical Resources5 products
- Siemens IMMULITE allergen test kits recalled for barcode scanning error
Siemens is recalling three IMMULITE allergen test products used with IMMULITE 2000 and IMMULITE 2000 XPi instruments. When paired with a Zebra barcode scanner, the barcode orientation can cause the instrument to misread the position of tubes in the allergen holder wedge. No injuries have been reported. The recall covers 2,864 units, with only one unit distributed in the US, and the rest sent to other countries.
ModerateFDANov 19, 20253 products
- HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
FDANov 19, 2025
- Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
FDANov 19, 2025
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDANov 19, 2025
- Covidien Signia staplers recalled for uncontrolled motion risk
Covidien is recalling two Signia small diameter curved tip intelligent reloads because a manufacturing issue can cause a malformed cover tube press. This can let internal components move during firing, creating a risk of uncontrolled motion. No injuries have been reported.
ModerateFDANov 19, 20252 products
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
FDANov 19, 2025
- Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
FDANov 19, 20252 products
- SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
FDANov 19, 2025
- GM85 Digital Mobile X-ray imaging System; Model Number: GM85;
The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.
FDANov 19, 2025NeuroLogica
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
FDANov 19, 2025Miach Orthopaedics
- Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm;
Polyaxial screws do not meet performance standards.
FDANov 19, 2025
- Medline Renewal LigaSure surgical devices recalled for trapped material
Medline Renewal has determined that certain areas of these LigaSure electrosurgical devices can trap residual material, which may remain inside the device and, in rare cases, become dislodged. The recall covers 11 products, and no injuries have been reported.
ModerateFDANov 19, 202511 products