The Recall Desk

State

Indiana product recalls

72,907 recalls have nationwide distribution and so reach Indiana. 9,555 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,555
Critical
1,903
Severe
2,136
Most recent
2026-09-09

Of the 9,555 recalls naming Indiana we have scored against our rubric, 1,903 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,136 (22%) are Severe.

These figures cover only the 9,555 recalls whose distribution notice names Indiana specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1101–1125 of 82462

  • 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 (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-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-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-2560-2026·2026-07-01

    Surgify Halo surgical burr recalled for potential breakage risk

    Surgify Medical is recalling the Surgify Halo 4.0 mm surgical burr because it may break during bi-portal endoscopic spinal surgery. The device is distributed nationwide.

    Product
    Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0622-2026·2026-07-01

    ChloraPrep One-Step antiseptic solution sterility assurance recall

    CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal area, compromising sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2026·2026-07-01

    GE Healthcare AW Server Radiological Image Processing System Software Defect

    GE Healthcare is recalling the AW Server 3.2 ext. 6.5 radiological image processing system due to a software synchronization issue that may cause the wrong patient's images to be displayed without warning, potentially leading to misdiagnosis.

    Product
    GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2026·2026-07-01

    Surgify Halo Surgical Burrs Subject to Potential Breakage Recall

    Surgify Halo 5.4 mm surgical burrs may break during bi-portal endoscopic spinal surgery. The FDA has classified this as a Class II recall affecting devices distributed nationwide.

    Product
    Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2026·2026-07-01

    Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall

    Zimmer, Inc. is recalling the Off-Axis Comprehensive Shoulder System reamer guides (Model 110040242) due to plastic guides that can catch and break during reaming. Five complaints have been received.

    Product
    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2026·2026-07-01

    Thuvera Laser Console Software Version 2.2 Recall Notice

    IPG Medical Corporation is recalling the Thuvera Laser Console (Software Version 2.2) due to a software anomaly that causes false display of error code 5018. The defect affects 198 units distributed nationwide in Massachusetts.

    Product
    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2026·2026-07-01

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

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

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2575-2026·2026-07-01

    Octopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error

    Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.

    Product
    Octopus Evolution Tissue Stabilizer, Model TS2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2026·2026-07-01

    Corlanor ivabradine tablets recalled for presence of foreign substance

    Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.

    Product
    CORLANOR — CORLANOR (IVABRADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0614-2026·2026-07-01

    Sensipar Cinacalcet Tablets Recalled Due to CGMP Deviations

    Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2026·2026-07-01

    Octopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall

    Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.

    Product
    Octopus Evolution AS Tissue Stabilizer, Model TS2500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2026·2026-07-01

    Philips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall

    Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2026·2026-07-01

    Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2595-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2026·2026-07-01

    Duloxetine 30 mg capsules recalled for impurity above FDA limits

    Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.

    Product
    DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0627-2026·2026-07-01

    Povi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency

    Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.

    Product
    POVI-ONE — POVI-ONE (POVIDONE-IODINE 10% TOPICAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2526-2026·2026-07-01

    Multi-Snare Set catheter fails biocompatibility requirements

    PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.

    Product
    Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2026·2026-07-01

    METHYLERGONOVINE MALEATE Tablets 0.2 mg Drug Recall

    The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide