Arca

FDA this week

Oct 26 to Nov 1, 2026

What FDA published for drug, device and biologics teams: 15 warning letters, 4 OAI inspections, 32 recalls, 3 new guidances, 12 Federal Register documents.

Warning letters 15

Inspections classified Official Action Indicated 4

Recalls 32

Instrumentation LaboratoryClass I

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) (and 1 more product)

Class I · Device · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

Full record

American Health Packaging

Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC…

Class II · Drug · Presence of Foreign Tablets/Capsules

Full record

Baxter Healthcare Corporation

Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES…

Class II · Device · Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected…

Full record

Beckman Coulter, Inc.

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 (and 1 more product)

Class II · Device · The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded…

Full record

Becton Dickinson & Co.

BD Phoenix Panel NMIC-312. Catalog Number: 449082. (and 1 more product)

Class II · Device · Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

Full record

BioFire Diagnostics, LLC

Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30… (and 2 more products)

Class II · Device · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

Full record

Boston Scientific Corporation

NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;

Class II · Device · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.

Full record

Cadwell Industries Inc

Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The…

Class II · Device · Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended…

Full record

Cook Incorporated

Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part…

Class II · Device · The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur…

Full record

Ethicon, LLC

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H

Class II · Device · Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause…

Full record

Ferno-Washington Inc

Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium…

Class II · Device · Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or…

Full record

Healthmark Industries Co., Inc.

Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD…

Class II · Device · Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.

Full record

Houston Rx LLC

Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032. (and 1 more product)

Class II · Drug · Lack of process control

Full record

Howmedica Osteonics Corp.

TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. (and 3 more products)

Class II · Device · Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small…

Full record

In2bones USA, LLC

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

Class II · Device · Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Full record

INTEGRATED MEDCRAFT LLC

FORWARD Gunshot Wound Kit; Model: AFT-GSW;

Class II · Device · Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The…

Full record

INTELERAD MEDICAL SYSTEMS INCORPORATED

IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through…

Class II · Device · Following a Chromium-based web-browser, report and displayed images may not match.

Full record

Jenavalve Technology Inc.

JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L (and 2 more products)

Class II · Device · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.

Full record

Medline Industries, LP

Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY… (and 11 more products)

Class II · Device · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Full record

Medline Industries, LP

Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A

Class II · Device · Discrepancy in the shelf-life of a component

Full record

Medline Industries, LP

Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M (and 5 more products)

Class II · Device · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending…

Full record

Medtronic Sofamor Danek USA Inc

Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone… (and 1 more product)

Class II · Device · Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms…

Full record

Merit Medical Systems, Inc.

Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance…

Class II · Device · The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.

Full record

Microgenics Corporation

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated…

Class II · Device · Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in…

Full record

Neuronetics, Inc.

NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced…

Class II · Device · Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Full record

Radiometer Medical ApS

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is…

Class II · Device · In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing…

Full record

Sarnova HC, Llc

Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT

Class II · Device · Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.

Full record

SI-BONE, Inc.

iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)

Class II · Device · The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

Full record

Steris Corporation

RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 (and 2 more products)

Class II · Device · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the…

Full record

Teva Pharmaceuticals USA, Inc

Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054…

Class II · Drug · Presence of Foreign Tablets/Capsules

Full record

W L Gore & Associates, Inc.

Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE…

Class II · Device · The potential for the devices to be mislabeled with the incorrect length.

Full record

Zydus Pharmaceuticals (USA) Inc

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510…

Class II · Drug · Failed Impurities/Degradation Specifications.

Full record

New guidance documents 3

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for Industry

Final · CDER

Read at FDA

Electronic Submission Template for Investigational Device Exemption (IDE) Applications: Draft Guidance for Sponsors and Food and Drug Administration Staff

Draft · CDRH · comments close 2026-12-28

Read at FDA

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management

Draft · CBER · comments close 2026-11-27

Read at FDA

Federal Register: rules, proposed rules and notices 12

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability

Notice · comments close 2027-01-28

Read in the Federal Register

Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea

Final rule · effective 2026-10-30

Read in the Federal Register

Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

Final rule · effective 2026-10-30

Read in the Federal Register

Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease

Final rule · effective 2026-10-30

Read in the Federal Register

Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer

Final rule · effective 2026-10-30

Read in the Federal Register

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation…

Notice · effective 2026-05-27

Read in the Federal Register

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability

Notice · comments close 2026-11-27

Read in the Federal Register

Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

Notice · comments close 2026-12-28

Read in the Federal Register

Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)

Notice

Read in the Federal Register

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