Arca

FDA this week

Oct 2 to Oct 8, 2026

What FDA published for drug, device and biologics teams: 15 warning letters, 31 recalls, 3 new guidances.

Warning letters 15

Recalls 31

AVID Medical, Inc.Class I

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

Class I · Device · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.

Full record

Boston Scientific CorporationClass I

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER…

Class I · Device · Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Full record

CooperSurgical, Inc.Class I

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712… (and 1 more product)

Class I · Device · Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the…

Full record

Abiomed, Inc.

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA…

Class II · Device · Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal…

Full record

Amneal Pharmaceuticals of New York, LLC

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured…

Class II · Drug · Defective Delivery System: Possibility of no medication in the prefilled pen.

Full record

AVID Medical, Inc.

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02 (and 1 more product)

Class II · Device · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Full record

Baxter Healthcare Corporation

PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide… (and 2 more products)

Class II · Device · There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may…

Full record

Baxter Healthcare Corporation

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA…

Class II · Device · Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet…

Full record

Becton, Dickinson and Company

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use…

Class II · Device · Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

Full record

Biomerieux Inc

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Class II · Device · The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false…

Full record

Cardinal Health 200, LLC

Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT… (and 1 more product)

Class II · Device · The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to…

Full record

CooperVision, Inc.

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

Class II · Device · A small number of lenses within the affected lot are of the incorrect power.

Full record

Criticare Technologies, Inc.

nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT…

Class II · Device · Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Full record

DeRoyal Industries Inc

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

Class II · Device · Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

Full record

Fresenius Medical Care Renal Therapies Group, LLC

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

Class II · Device · Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Full record

Heidelberg Engineering GmbH

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610…

Class II · Device · Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or…

Full record

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz… (and 1 more product)

Class II · Drug · Lack of Assurance of Sterility

Full record

INTERVASCULAR, SAS

Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5…

Class II · Device · Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).

Full record

Maquet SAS

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Class II · Device · The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Full record

Medline Industries, LP

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F. (and 1 more product)

Class II · Device · Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut…

Full record

Medline Industries, LP

Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3)… (and 4 more products)

Class II · Device · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical…

Full record

Midmark Corporation

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal)… (and 3 more products)

Class II · Device · A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Full record

New York Embroidery Studio, Inc.

New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs…

Class II · Device · Gowns do not consistently meet the minimum liquid-barrier performance required.

Full record

Olympus Corporation of the Americas

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. (and 3 more products)

Class II · Device · Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Full record

Olympus Corporation of the Americas

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

Class II · Device · Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Full record

Philips North America Llc

Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345; (and 11 more products)

Class II · Device · A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system…

Full record

Philips Ultrasound, LLC

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Class II · Device · Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and…

Full record

SEASPINE ORTHOPEDICS CORPORATION

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Class II · Device · The proximal thread depth of the spinal device is out of design specification.

Full record

SHANTOU Qiwei industrial Co., Ltd

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building…

Class II · Drug · cGMP Deviations

Full record

Sterling Pharmaceutical Services LLC

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles… (and 8 more products)

Class II · Drug · Lack of Assurance of Sterility

Full record

Ventec Life Systems, Inc.

REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve (and 2 more products)

Class II · Device · Labeling; Oxygen Cylinders do not contain required medical gas labeling

Full record

New guidance documents 3

Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry

Final · CDER

Read at FDA

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers

Final · CDER

Read at FDA

Study Data Technical Conformance Guide - Technical Specifications Document

Final · CDER

Read at FDA