Recall Atlas: drugs & medical recalls

Azurion 7 Systems

Thu, 22 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-21

Official notice · On Recall Atlas

i-STAT hs-TnI Cartridge

Thu, 22 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-21

Official notice · On Recall Atlas

FP3D™ Resins

Thu, 22 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-21

Official notice · On Recall Atlas

Femyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.

Thu, 22 Oct 2026 12:00:00 +0000

Packaging

The Government of Canada · Canada · 2026-10-21

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 recall, that may…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 or incorrect…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

LeMaitre Vascular, Inc. recalls TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;

Wed, 21 Oct 2026 12:00:00 +0000

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

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Mindray DS USA, Inc. recalls ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A

Wed, 21 Oct 2026 12:00:00 +0000

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5

Wed, 21 Oct 2026 12:00:00 +0000

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

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

Wed, 21 Oct 2026 12:00:00 +0000

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, potentially resulting…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

Wed, 21 Oct 2026 12:00:00 +0000

Product may be potentially contaminated with a lubricant used during the manufacturing process.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Wed, 21 Oct 2026 12:00:00 +0000

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 visualization of alarms.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 functional tests. The…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Medline Industries, LP recalls Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide…

Wed, 21 Oct 2026 12:00:00 +0000

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 become loose or detach…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 or ganuloma…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520

Wed, 21 Oct 2026 12:00:00 +0000

Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Beckman Coulter Inc. recalls 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…

Wed, 21 Oct 2026 12:00:00 +0000

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 the system…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

DRG International, Inc. recalls Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

Wed, 21 Oct 2026 12:00:00 +0000

Potential for false negative patient results.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

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 infection.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Limitless Cryo Spa LLC recalls Glypto Device, Glypto Cryo Machine;

Wed, 21 Oct 2026 12:00:00 +0000

Lack of 510(k) clearance.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Cardinal Health 200, LLC recalls Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J…

Wed, 21 Oct 2026 12:00:00 +0000

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 tube to perform a…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

PHILIPS MEDICAL SYSTEMS recalls 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…

Wed, 21 Oct 2026 12:00:00 +0000

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.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

GRI Medical & Electronic Technology Co., Ltd. recalls HALYARD Laparoscopy Comprehensive Pack II REF: 49332

Wed, 21 Oct 2026 12:00:00 +0000

Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

Due to a manufacturing issue (inadequate weld) for patient head positioning system.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Steris Corporation recalls VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

Wed, 21 Oct 2026 12:00:00 +0000

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 biological…

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Medical Action Industries, Inc. 306 recalls Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number:…

Wed, 21 Oct 2026 12:00:00 +0000

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Apothecary Pharma LLC recalls Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC…

Wed, 21 Oct 2026 12:00:00 +0000

Lack of Assurance of Sterility

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

SUN PHARMACEUTICAL INDUSTRIES INC recalls Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro…

Wed, 21 Oct 2026 12:00:00 +0000

Failed Impurities/Degradation Specifications

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Carolina Infusion, LLC recalls TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…

Wed, 21 Oct 2026 12:00:00 +0000

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Carolina Infusion, LLC recalls QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…

Wed, 21 Oct 2026 12:00:00 +0000

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

Presence of particulate matter.

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

Failed Impurities/Degradation Specifications

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

Failed Content Uniformity Specifications

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

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

Wed, 21 Oct 2026 12:00:00 +0000

Failed stability specifications

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

K.C. Pharmaceuticals, Inc. recalls Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017,…

Wed, 21 Oct 2026 12:00:00 +0000

Lack of Assurance of Sterility

The US Food and Drug Administration · United States · 2026-10-14

Official notice · On Recall Atlas

Dantrium Intravenous (Dantrolene sodium for injection): Presence of particulate matter

Tue, 20 Oct 2026 12:00:00 +0000

Contamination

The Government of Canada · Canada · 2026-10-19

Official notice · On Recall Atlas

IQecg® Digital ECG

Mon, 19 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-19

Official notice · On Recall Atlas

SIGNA™ Architect

Sat, 17 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-16

Official notice · On Recall Atlas

ARCHITECT "I" System - i2000SR Processing Module - Class 4

Sat, 17 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-16

Official notice · On Recall Atlas

NICO Myriad™ 19x21.5 MHP Paediscope

Sat, 17 Oct 2026 12:00:00 +0000

Device compatibility

The Government of Canada · Canada · 2026-10-16

Official notice · On Recall Atlas

Cochlear Implant Model CI1012

Fri, 16 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

EMIT® 2000 Quinidine Assay

Fri, 16 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

HemosIL AcuStar HIT-IgG(PF4-H)

Fri, 16 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

Flintstones Complete Multivitamins and Minerals: Recalled from wholesalers (Distribution Error)

Fri, 16 Oct 2026 12:00:00 +0000

Other

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

cobas® c 303 analytical unit

Fri, 16 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

Claritin Allergy Tablets 10 mg: Recalled from wholesalers (Distribution Error)

Fri, 16 Oct 2026 12:00:00 +0000

Other

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

Aleve 200 mg caplets: Recalled from wholesalers (Distribution Error)

Fri, 16 Oct 2026 12:00:00 +0000

Other

The Government of Canada · Canada · 2026-10-15

Official notice · On Recall Atlas

CareLink™ SmartSync™ Device Manager

Thu, 15 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-14

Official notice · On Recall Atlas

Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter

Thu, 15 Oct 2026 12:00:00 +0000

Performance

The Government of Canada · Canada · 2026-10-14

Official notice · On Recall Atlas