The Recall Desk

State

Delaware product recalls

72,907 recalls have nationwide distribution and so reach Delaware. 3,435 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total
3,435
Critical
477
Severe
937
Most recent
2026-09-09

Of the 3,435 recalls naming Delaware we have scored against our rubric, 477 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 937 (27%) are Severe.

These figures cover only the 3,435 recalls whose distribution notice names Delaware specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1001–1025 of 76342

  • SevereFDA (Devices)·Z-2585-2026·2026-07-01

    Medline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The recall affects 113,843 kits distributed nationwide and in Barbados.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2455-2026·2026-07-01

    Medline Convenience Kits Medical Devices Recalled for Quality Issues

    Medline Industries is recalling four models of Convenience Kits containing Lidocaine and Bupivacaine injections due to quality issues identified during an FDA inspection of the supplier.

    Product
    Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2583-2026·2026-07-01

    Medical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes used in surgical procedures. The manufacturer identified unapproved design changes to the products that were not cleared by the FDA through the 510(k) process.

    Product
    Convenience 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2521-2026·2026-07-01

    Da Vinci surgical system operative components with E-brake retainer pin defect

    Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.

    Product
    Da Vinci ASSY, PSS, SP1098, Part Number: 380601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2600-2026·2026-07-01

    Abiomed Impella CP Introducer Kit Recalled for Thrombus Risk

    Abiomed is recalling the 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP due to potential thrombus formation during prolonged use. The recall affects 17 units distributed in the United States and Japan.

    Product
    Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2026·2026-07-01

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside FDA-cleared specifications.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2599-2026·2026-07-01

    Abiomed Impella CP Introducer Kit recalled for thrombus formation risk

    Abiomed is recalling 3 units of the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP due to potential for blood clot formation during prolonged use.

    Product
    Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2452-2026·2026-07-01

    Medline Convenience Kits containing anesthesia components recalled for quality issues

    Medline Industries is recalling Medline Convenience Kits (models DYNJ905503F and DYNJ905503G) that contain Arrow Kits with Lidocaine Hydrochloride Injection and Bupivacaine Hydrochloride in Dextrose Injection due to quality issues found during an FDA inspection of the supplier.

    Product
    Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2026·2026-07-01

    Surgify Halo Surgical Burr Potential Breakage During Endoscopic Spinal Surgery

    Surgify Medical is recalling Surgify Halo 3.0 mm Extendable surgical burrs because they may break during bi-portal endoscopic spinal surgery, posing a risk to patients.

    Product
    Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2568-2026·2026-07-01

    Surgify Halo Surgical Burr Breakage Risk During Spinal Surgery

    Surgify Medical is recalling Surgify Halo 5.4 mm Medium surgical burrs due to potential burr breakage during bi-portal endoscopic spinal surgery. The device poses a risk of fragmentation that could complicate surgical procedures.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2026·2026-07-01

    Surgify Halo Surgical Burrs Recalled Due to Breakage Risk

    SURGIFY MEDICAL OY is recalling Surgify Halo 5.4 mm Extendable surgical burrs (Model 54.000.SEE.H1) due to potential for burr breakage during bi-portal endoscopic spinal surgery. The device has been distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2557-2026·2026-07-01

    Surgify Halo surgical drill recalled for potential burr breakage

    Surgify Halo 3.0 mm surgical drills may experience burr breakage during bi-portal endoscopic spinal surgery. The FDA is requesting the recall of this device across multiple US states.

    Product
    Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2026·2026-07-01

    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall

    Boston Scientific Corporation is recalling the Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to potential leakage along the drug pathway from the pump through the catheter.

    Product
    Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2559-2026·2026-07-01

    Surgify Halo spinal surgery burr tool potential breakage recall

    Surgify Halo 4.0 mm extendable surgical burrs may break during bi-portal endoscopic spinal surgery. The device is being recalled to prevent patient injury from burr fragments.

    Product
    Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2026·2026-07-01

    Surgify Halo surgical burrs recalled for potential breakage during spinal surgery

    Surgify Medical OY is recalling Surgify Halo 5.4 mm Long surgical burrs due to potential breakage during bi-portal endoscopic spinal surgery. The defect could affect patient safety during the procedure.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2026·2026-07-01

    Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage

    Zimmer is recalling Off-Axis Comprehensive Shoulder System reamer guides (Model 110040241) because plastic guides can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2026·2026-07-01

    TMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled

    TMJ Solutions Inc is recalling TMJ Bilateral Implants (REF: CHG020) because some units may contain incorrect patient-specific components, causing poor implant fit and right-sided open bite.

    Product
    TMJ Bilateral Implants, REF: CHG020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2026·2026-07-01

    Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall

    Zimmer, Inc. is recalling the Off-Axis Alliance Glenoid Left 4-Peg Augment Reamer Guide because the plastic guides can catch during reaming and break. Five complaints have been received.

    Product
    Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0626-2026·2026-07-01

    Lacosamide 100mg Tablets Recalled Due to Foreign Tablet Contamination

    Annora Pharma is recalling Lacosamide 100mg tablets nationwide after discovering Selexipag 1000 mcg tablets mixed into bottles. Patients taking the wrong medication could experience unintended health effects.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2573-2026·2026-07-01

    Surgify Halo Surgical Burr May Break During Spinal Surgery

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The recalled burrs have UDI 06429811532335 and were distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2026·2026-07-01

    Philips Avalon Fetal Monitor FM 30 Speaker Connector Assembly

    Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2026·2026-07-01

    Surgify Halo surgical drill equipment recalled for potential burr breakage

    Surgify Halo 3.0 mm Short surgical drills and burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially leaving fragments in the patient.

    Product
    Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2026·2026-07-01

    Surgify Halo Surgical Burr Recalling Potential Tool Breakage Risk

    SURGIFY MEDICAL OY is recalling the Surgify Halo 5.4 mm Extendable surgical burr due to risk of burr breakage during bi-portal endoscopic spinal surgery (BESS). The recalled units are distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2026·2026-07-01

    Medline Industries Polycarbonate Syringes Convenience Kits Design Change Recall

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. Affected kits were distributed nationwide and internationally.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ680
    Category
    Medical Device
    Distribution
    Distributed nationwide