FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 3, 2026. New recalls appear here on the FDA's own publishing schedule.

59,102 recall(s)

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue catheter has not been studied.

Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Root cause: Process control

Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1914-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue catheter has not been studied

Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Root cause: Process control

Recalling firm: ARROW INTERNATIONAL, LLCType: I.V. Start KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1915-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Root cause: Process control

Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter Introducer KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1916-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

Root cause: Process control

Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter Introducer KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1917-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 27, 2026

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Reason: X-Ray generator may malfunction resulting in the X-Ray being inoperable.

Root cause: Component design/selection

Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.Recall #Z-1918-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

Reason: The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Root cause: Process control

Recalling firm: Windstone Medical Packaging, Inc.Type: Kit, Surgical Instrument, DisposableDistribution: US Nationwide distribution in the states of GA, OR, TN, and WA.Recall #Z-1919-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

Root cause: Process control

Recalling firm: Windstone Medical Packaging, Inc.Type: Kit, Surgical Instrument, DisposableDistribution: US Nationwide distribution in the states of GA, OR, TN, and WA.Recall #Z-1920-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Root cause: Process control

Recalling firm: Windstone Medical Packaging, Inc.Type: Kit, Surgical Instrument, DisposableDistribution: US Nationwide distribution in the states of GA, OR, TN, and WA.Recall #Z-1921-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 16, 2026

Access Total T4 Calibrator, Catalog No. 33805

Reason: Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Root cause: Nonconforming Material/Component

Recalling firm: Beckman Coulter, Inc.Type: Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bangladesh, Bolivia (Plurinational State of), Bosnia and Herzegovina, Brazil, Canada, China, C¿te d'Ivoire, Croatia, Czechia, Denmark, Egypt, El Salvador, Ethiopia, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Kosovo, Lebanon, Libya, Malawi, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, Uzbekistan, Viet Nam, Yemen.Recall #Z-1922-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Reason: Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

Root cause: Under Investigation by firm

Recalling firm: Remel Europe Ltd.Type: Antisera, All Groups, Salmonella Spp.Distribution: Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.Recall #Z-1923-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 16, 2026

Flamingo Funnel Small, Model Number SQ20012-01

Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Root cause: Packaging change control

Recalling firm: SurgiSmoke SolutionsType: Apparatus, Exhaust, SurgicalDistribution: Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.Recall #Z-1924-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 16, 2026

Flamingo Funnel Medium, Model Number SQ20012-02

Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Root cause: Packaging change control

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 16, 2026

Flamingo Funnel Large, Model Number SQ20012-03

Reason: Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.

Root cause: Packaging change control

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 20, 2026

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Reason: Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants

Root cause: Under Investigation by firm

Recalling firm: Foundation Medicine, Inc.Type: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemDistribution: US Nationwide distribution in the states of Massachusetts and North Carolina.Recall #Z-1927-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1928-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1929-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: Blood And Urine Collection Kit (Excludes Hiv Testing)Distribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1930-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: Dressing Change TrayDistribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1931-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: I.V. Start KitDistribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1932-2026

Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 9, 2026

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

Reason: Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.

Root cause: Under Investigation by firm

Recalling firm: LSL Healthcare Inc.Type: Suture KitDistribution: US Nationwide distribution in the states of MD, IL, MN.Recall #Z-1933-2026