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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 281–300 of 39,430 recalls

Class IIOngoing

Plum Duo Precision IV Pump, 40002-0403

ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

April 29, 2026 · DeviceView details →
Class IIOngoing

Plum Duo Infusion Pump, 40002-0401

ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

April 29, 2026 · DeviceView details →
Class IIOngoing

Plum Solo Precision IV Pump, 40001-0401

ICU Medical, Inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

April 29, 2026 · DeviceView details →
Class IIOngoing

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

April 28, 2026 · DeviceView details →
Class IIOngoing

SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston

Mentor Texas LP

A single lot of expired syringes were distributed due to a distribution system control failure.

April 28, 2026 · DeviceView details →
Class IIOngoing

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

April 28, 2026 · DeviceView details →
Class IIOngoing

Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

April 28, 2026 · DeviceView details →
Class IIOngoing

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

April 28, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: DAVINCI MAIN DYNJ908031D

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ908828D CERVICAL CDS DYNJ903477J CMC ORTHO BACK TRAY SYNJ10272B CRANIOTOMY DYNJ911853 CRANIOTOMY ROOSEVELT PACK DYNJ58358F CUSTOM HAND PACK-LF DYNJ0537135V CUSTOM SPINAL PACK DYNJT7544 DISCECTOMY PACK DYNJ86770 DJ ORTHO SPINE DYNJ48980M EXTREMITY PACK-LF DYNJT4161 FOOT PACK DYNJ53179D GENERAL ORTHO-ACNW DYNJ84891 GILMORE SHOULDER SCOPE PACK DYNJ58002 GV LUMBAR LAMINECTOMY PK DYNJ46938L HAND PACK DYNJ63113B DYNJ69662A DYNJT5855 HAND-LF DYNJ903263B KIT LAMINECTOMY DYNJ908806C KNEE ARTHROSCOPY DYNJ902056C DYNJ904846I KNEE ARTHROSCOPY-LF DYNJ905871F KNEE SCOPE DYNJ906986G LAMINECTOMY DYNJ904847K DYNJ909505D LAMINECTOMY CDS CDS983115K LAMINECTOMY CERVICAL DISC-LF DYNJ905286G LAMINECTOMY NEURO PACK DYNJ58356F LAMINECTOMY SPINE DYNJ904139L LOWER EXTREMITY PACK DYNJ63114C LUMBAR CERVICAL PACK-LF DYNJ0101088G LUMBAR LAMI DYNJ905020J LUMBAR LAMINECTOMY DYNJ53707 LUMBAR LAMINECTOMY PACK DYNJT4386 MAIN/LAMINECTOMY PACK-LF DYNJ0565499AN NJ SPINE SPECIALIST PACK DYNJ58706F OHOW SPINE-BACK PACK DYNJ910097A ORTHO NECK CDS-LF CDS983134C ORTHO PACK-LF DYNJ37202G ORTHO SPINE DYNJ40221G OSC BEACH CHAIR SHOULDER-LF DYNJ905282C PACC PETRIE ACL ADD ON PACK-LF DYNJ58290D PACK,ARTHROSCOPY ASC DYNJ65484A PACK,POSTERIOR SPINAL FUSION DYNJ906892B PAD LATERAL SPINE DYNJ902158L DYNJ902158M PAD POSTERIOR SPINE DYNJ902142L PK-SPINE DYNJ58259A PODIATRY PACK DYNJ62288D POST SPINE PACK DYNJ20509R POSTERIOR SPINAL FUSION DYNJ903250B RFT ARTHROSCOPY PACK DYNJ43956C RFT SHOULDER PACK-NOBLE DYNJ36331D SA SHOULDER #2 BORDEN DYNJ56501A SHOULDER DYNJ900893M DYNJ904184I SHOULDER ARTHROSCOPY DYNJ904842G SHOULDER PACK DYNJ83483 SHOULDER PACK-LF DYNJ42973N SHOULDER SCOPE PACK NTX DYNJ68399C SPINAL PACK DYNJ49692G SPINE DYNJ910451A SPINE PACK DYNJ20147O DYNJ84971 DYNJ86044A DYNJ86308C DYNJ88917 DYNJS3069 DYNJT4163 DYNJT8396 ST CHARLES TOTAL HIP DYNJ909593C TOTAL HIP DYNJ910906D TOTAL HIP PACK DYNJ64156B TOTAL JOINT DYNJ904186G TOTAL KNEE PACK DYNJ60967 DYNJ61409A WMC ORTHO SPINE WMC-LF DYNJ902528M XLIF DYNJ910795B

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IOngoing

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405637, 405707.

Becton Dickinson & Company

This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

April 27, 2026 · DeviceView details →
Class IIOngoing

BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kits: WT LAVH PACK DYNJ46609F

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
Class IIOngoing

MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G

Medline Industries, LP

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

April 27, 2026 · DeviceView details →
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