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Search or scan any product against every CPSC, FDA, USDA, and NHTSA recall on record — or read the last 90 days below.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for unapproved design changes
Medline Industries identified unapproved design changes to 10mL syringes in certain C-Section Tray convenience kits that were not cleared by the FDA under the original product authorization. The affected kits were distributed nationwide and to Barbados.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. These design changes were not part of the original FDA clearance for these products. The kits are used in medical settings for procedures like central line insertion, vascular access, and fistula management.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified unapproved design changes in certain 10mL polycarbonate colored syringes used in medical convenience kits. These changes were made outside the FDA-cleared design and were not originally reported to the FDA. The affected kits were distributed nationwide to healthcare facilities.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline medical kits recalled for unapproved syringe design changes
Medline Industries recalled over 113,000 convenience kits containing 10mL polycarbonate colored syringes used in cardiac and interventional radiology procedures. The firm made design changes to the syringes that were not approved by the FDA in the original product clearance. These kits were distributed nationwide.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified with design changes that were not approved by the FDA. These kits are used in surgical and medical procedures including cataract surgery, vascular interventions, and spine procedures.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were modified in ways that were not approved by the FDA. The changes were made outside the scope of the FDA clearance originally granted for these products.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline convenience kits recalled for unapproved design changes
Medline Industries identified that certain 10mL polycarbonate colored syringes included in Major Basin Set convenience kits (model DYNJ85723) were modified in ways that were not approved by the FDA. These design changes were made outside of the FDA clearance process. Approximately 113,843 kits containing these syringes have been distributed nationwide.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for unapproved design changes
Medline Industries identified that certain surgical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were distributed nationwide and include craniotomy, spine, laminectomy, and neuro packs used in operating rooms.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes used in neurological and angiography procedures contained design changes that were not reviewed or cleared by the FDA. These products were distributed nationwide and include multiple SKUs across neuro packs, angio packs, and related surgical kits.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline surgical kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The kits were sold nationwide and include various surgical and procedural trays used in hospitals and medical facilities.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Dr G's Breast Pack, Lipo Supplement Pack-LF, and Plastic Pack products distributed nationwide.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline convenience kits recalled for unapproved design changes
Medline Industries identified that certain medical convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not reviewed or approved by the FDA. These kits are used in cardiac catheterization, angiography, and other medical procedures. The firm has initiated a recall of affected lots.
- 2026-07-01FDA-DeviceMedline Industries, LPClass IIMedline syringe kits recalled for unapproved design changes
Medline Industries identified that certain convenience kits containing 10mL polycarbonate colored syringes were manufactured with design changes that were not approved by the FDA. The affected kits include Angiogram Pack-LF and Judkins Pack models distributed nationwide.
- 2026-07-01FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific INTERA 3000 pump recalled for drug leakage risk
Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.
- 2026-07-01FDA-DevicePhilips North America LlcClass IIPhilips Telemetry Monitor 5500 recalled for reset risk
Philips Telemetry Monitor 5500 (model 867232) devices may unexpectedly reset to a default state, causing them to lose their configuration settings and disconnect from the hospital's central monitoring system. This could prevent the monitor from reconnecting to the PIC iX central system until manually reconfigured.
- 2026-07-01FDA-DeviceZimmer, Inc.Class IIZimmer Persona Revision augment recalled for packaging error
Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.
- 2026-07-01FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Octopus 4 Tissue Stabilizer recalled for assembly error
During manufacturing, Medtronic discovered that tubing was installed backwards on some Octopus 4 Tissue Stabilizer devices: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This affects 590 units with specific serial numbers distributed nationwide.
- 2026-07-01FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Octopus Evolution AS Tissue Stabilizer recalled for tubing assembly error
Medtronic identified a manufacturing defect in certain Octopus Evolution AS Tissue Stabilizer units where the tubing was installed backwards—the short tube was attached to the bottom and the long tube to the top, opposite the correct design. This incorrect assembly could affect proper operation during surgical use. The issue affects 288 units distributed worldwide.
- 2026-07-01FDA-DeviceMedtronic Perfusion SystemsClass IIMedtronic Octopus Evolution Tissue Stabilizer recalled for assembly error
Medtronic identified a manufacturing defect in certain Octopus Evolution Tissue Stabilizer units where the tubing was installed backwards: the short tube was attached to the bottom of the canister and the long tube to the top, opposite of the correct design. This incorrect assembly could affect the device's proper function during use.
- 2026-07-01FDA-DeviceDexcom, Inc.Class IIDexcom G7 sensors recalled for infection and accuracy risks
Certain lots of Dexcom G7 continuous glucose monitoring sensors that were designated for destruction were stolen and later sold to pharmacies and distributors without authorization. Two affected lots have different risks: one was not properly sterilized and poses an infection risk, and the other may not provide accurate readings or detect dangerous blood sugar levels.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage during spinal surgery
Surgify Medical's Halo 5.4 mm burr (Model 54.140.SHD.U1) used in spinal surgery may break during the procedure. This could leave fragments inside the surgical site or require additional intervention. The issue affects all lots distributed in the US until an updated instruction document is provided.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage risk during spine surgery
Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during use. The company has identified this risk and is notifying healthcare facilities.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage risk
Surgify Medical's Halo 5.4 mm burr (model 54.125.NVG.U1) may break during bi-portal endoscopic spinal surgery. The company has identified this risk and is working to update instructions for use. No injuries have been reported.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage risk
Surgify Medical's Halo 5.4 mm burr (Model 54.125.NVG.H1) may break during bi-portal endoscopic spinal surgery. The device has been distributed across multiple U.S. states. No injuries have been reported.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage risk in spine surgery
Surgify Medical's Halo 5.4 mm burr, used in minimally invasive spinal surgery, may break during the procedure. The company has identified this risk and is recalling affected units.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo surgical burr recalled for breakage risk
Surgify Medical's Halo 5.4 mm surgical burr (Model 54.085.SHD.H1) may break during bi-portal endoscopic spinal surgery. The risk affects all product lots distributed in the US until updated instructions are implemented.
- 2026-07-01FDA-DeviceSURGIFY MEDICAL OYClass IISurgify Halo burr recalled for breakage risk in spinal surgery
Surgify Medical's Halo 5.4 mm burr (Model 54.070.NVG.U1) may break during bi-portal endoscopic spinal surgery (BESS). The risk affects all lots distributed in the U.S. until updated instructions are provided.