FDA Medical Device Recalls

Open, ClassifiedPosted Mar 12, 2026·Initiated Dec 19, 2025

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Reason: Product not cleared by the FDA.

Root cause: No Marketing Application

Recalling firm: Altruan GmbHType: Antigens, All Groups, Streptococcus Spp.Distribution: US Nationwide distribution.Recall #Z-1561-2026

Open, ClassifiedPosted Mar 12, 2026·Initiated Jan 30, 2026

Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

Reason: The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

Root cause: Error in labeling

Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.Recall #Z-1562-2026

Open, ClassifiedPosted Mar 12, 2026·Initiated Jan 28, 2026

Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL

Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

Root cause: Labeling Change Control

Recalling firm: Medline Industries, LPType: Gown, SurgicalDistribution: Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.Recall #Z-1563-2026

Open, ClassifiedPosted Mar 12, 2026·Initiated Jan 28, 2026

Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT

Reason: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

Root cause: Labeling Change Control

Recalling firm: Medline Industries, LPType: Drape, Surgical, ExemptDistribution: Domestic distribution nationwide US. International distribution to Panama, United Arab Emirates, Virgin Islands, Saudi Arabia, India, Chile, and Canada.Recall #Z-1564-2026

Open, ClassifiedPosted Mar 11, 2026·Initiated Feb 10, 2026

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

Root cause: Process control

Recalling firm: Boston Scientific CorporationType: Gastrointestinal Tubes With Enteral Specific ConnectorsDistribution: US Nationwide distribution.Recall #Z-1551-2026

Open, ClassifiedPosted Mar 11, 2026·Initiated Feb 6, 2026

Artelon FlexBand Dynamic Matrix Ref: 31057

Reason: Augmentation devices failed bacterial endotoxin testing.

Root cause: Process control

Recalling firm: International Life SciencesType: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.Recall #Z-1554-2026

Open, ClassifiedPosted Mar 11, 2026·Initiated Feb 6, 2026

Artelon FlexBand Plus Ref: 41054 & 41057

Reason: Augmentation devices failed bacterial endotoxin testing.

Root cause: Process control

Recalling firm: International Life SciencesType: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.Recall #Z-1555-2026

Open, ClassifiedPosted Mar 11, 2026·Initiated Feb 6, 2026

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

Reason: Augmentation devices failed bacterial endotoxin testing.

Root cause: Process control

Recalling firm: International Life SciencesType: Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.Recall #Z-1556-2026

Open, ClassifiedPosted Mar 11, 2026·Initiated Jan 30, 2026

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

Reason: Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.