Arca

FDA this week

Oct 19 to Oct 25, 2026

What FDA published for drug, device and biologics teams: 4 warning letters, 4 OAI inspections, 27 recalls, 3 new guidances, 2 Federal Register documents.

Apothecary, Carolina and K.C. repeat sterility recalls

  • Apothecary Pharma LLC recalled tirzepatide injection for lack of sterility assurance[1].
  • Medtronic MiniMed, Inc. recalled 25 Flex insulin pumps with incomplete verification testing[2].
  • FDA finalized drug labeling guidance for prescription drug use-related software[3].

Apothecary Pharma LLC recalled tirzepatide injection in 4 mL multi-dose vials for lack of assurance of sterility[1]. FDA had issued a December 2025 warning letter to the same Cary facility after documenting insanitary sterile production conditions and tirzepatide labeling gaps[1][4]. Carolina Infusion, LLC recalled tirzepatide combination injectables in syringes for lack of assurance of sterility[5]. The firm has a May 2023 warning letter and multiple Form 483s listed on the compounding inspections page[6].

K.C. Pharmaceuticals, Inc. recalled lubricant eye drops for lack of assurance of sterility[7]. FDA had cited the firm in August 2026 for failure to prevent microbiological contamination after media fill failures and for inadequate visual inspection for particulates[8]. J&J Innovative Medicine recalled IMAAVY injection for presence of particulate matter[9].

Medtronic MiniMed, Inc. recalled 25 MiniMed Flex insulin pumps that were released with missing or failed verification results in functional tests[2]. The firm instructed users to stop using the affected pumps and return to backup insulin therapy[2]. Nihon Kohden America LLC recalled 808 central nurse stations for a null pointer dereference cybersecurity vulnerability[10]. The vulnerability could disrupt centralized monitoring of multiple beds and visualization of alarms[10].

FDA finalized guidance describing how drug labeling authorities apply to software outputs disseminated by sponsors for use with prescription drugs[3]. FDA issued a final small business compliance guide on expedited safety reporting for INDs and exempt bioavailability and bioequivalence studies[11]. FDA also issued final technical specifications for submitting driving study data to support marketing applications for drugs and biologics[12].

Sources

Written with Arca Research, which cites every claim to its source.

Warning letters 4

Inspections classified Official Action Indicated 4

Recalls 27

Apothecary Pharma LLC

Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC… (and 1 more product)

Class II · Drug · Lack of Assurance of Sterility

Full record

AVID Medical, Inc.

ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11; (and 14 more products)

Class II · Device · Product may be potentially contaminated with a lubricant used during the manufacturing process.

Full record

Beckman Coulter Inc.

DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3… (and 1 more product)

Class II · Device · Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from…

Full record

BioSpectra, Inc.

Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

Class II · Drug · Failed stability specifications

Full record

Canon Medical System, USA, INC.

Alphenix INFX-8000C/B5

Class II · Device · Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

Full record

Cardinal Health 200, LLC

Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J…

Class II · Device · Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal…

Full record

Carolina Infusion, LLC

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific… (and 15 more products)

Class II · Drug · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Full record

Cipla USA, Inc.

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by…

Class II · Drug · Failed Impurities/Degradation Specifications

Full record

DRG International, Inc.

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

Class II · Device · Potential for false negative patient results.

Full record

GRI Medical & Electronic Technology Co., Ltd.

HALYARD Laparoscopy Comprehensive Pack II REF: 49332

Class II · Device · Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

Full record

Intellijoint Surgical, Inc.

Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP…

Class II · Device · A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery…

Full record

J&J INNOVATIVE MEDICINE

IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only…

Class II · Drug · Presence of particulate matter.

Full record

K.C. Pharmaceuticals, Inc.

Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017… (and 7 more products)

Class II · Drug · Lack of Assurance of Sterility

Full record

LeMaitre Vascular, Inc.

TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;

Class II · Device · Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Full record

Limitless Cryo Spa LLC

Glypto Device, Glypto Cryo Machine;

Class II · Device · Lack of 510(k) clearance.

Full record

Medline Industries, LP

Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate… (and 1 more product)

Class II · Device · The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may…

Full record

Medtronic MiniMed, Inc.

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed…

Class II · Device · Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9…

Full record

Nihon Kohden America LLC

Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03…

Class II · Device · Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the…

Full record

Onkos Surgical, Inc.

Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M (and 1 more product)

Class II · Device · Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Full record

PHILIPS MEDICAL SYSTEMS

Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333…

Class II · Device · Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.

Full record

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

Class II · Device · During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected…

Full record

Preferred Pharmaceuticals, Inc.

Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC)…

Class II · Drug · Failed Content Uniformity Specifications

Full record

QUANTUM OPS Inc

Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis)…

Class II · Device · Due to a manufacturing issue (inadequate weld) for patient head positioning system.

Full record

Safeguard US Operating LLC

Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol…

Class II · Device · Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and…

Full record

Steris Corporation

VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 (and 5 more products)

Class II · Device · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the…

Full record

Steris Corporation

HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and…

Class II · Device · A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy…

Full record

Stryker Sustainability Solutions

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

Class II · Device · Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus…

Full record

New guidance documents 3

Regulatory Considerations for Prescription Drug Use-Related Software

Final · CDER

Read at FDA

Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle

Final · CDER

Read at FDA

Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators

Final · CDER

Read at FDA

Federal Register: rules, proposed rules and notices 2

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