The Recall Desk

State

Indiana product recalls

73,737 recalls have nationwide distribution and so reach Indiana. 9,596 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,596
Critical
1,908
Severe
2,534
Most recent
2026-10-28

Of the 9,596 recalls naming Indiana we have scored against our rubric, 1,908 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,534 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,596 recalls whose distribution notice names Indiana specifically. The 73,737 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

32201–32225 of 83333

  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2020·2020-05-27

    Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure

    Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.

    Product
    Frames Direct Prescription Spectacle Lenses included in the frame brands
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2016-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2020·2020-05-27

    Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue

    The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.

    Product
    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2020·2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2020·2020-05-27

    BD Posiflush SF Saline Flush Syringe Recalled for Packaging Holes

    Becton Dickinson is recalling BD Posiflush SF Saline Flush Syringes because holes in the packaging may compromise the sterile field.

    Product
    BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2020·2020-05-27

    Medline Recalls Surgical Kits Due to Potential Loss of Sterility

    Medline is recalling 92,902 custom surgical convenience kits because packaging seal voids may have caused a loss of sterility on the outside of the foil pouch.

    Product
    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2020·2020-05-27

    Cardinal Health Recalls Urine Drug Controls Due to Temperature Abuse

    Cardinal Health is recalling Alere Professional Urine Drug Controls (Lot KN00146) because they were stored outside approved temperature ranges, which may result in patient misdiagnosis.

    Product
    Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2020·2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2020·2020-05-27

    Medline Recalls Silicone Foley Catheters Due to Loose Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E033000·2020-05-27

    Horizon Recalls Tekonsha Prodigy Electronic Brake Control Kits

    Horizon Global is recalling certain Tekonsha Prodigy electronic brake control kits because they do not adequately warn drivers that foot pedal trailer braking is unavailable when hazard signals are active.

    Product
    ELECTRICAL SYSTEM: INTEGRATED TRAILER BRAKE CONTROL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2020·2020-05-27

    Cardinal Health Recalls Strep B Carrot Broth Due to Temperature Abuse

    Cardinal Health is recalling Strep B Carrot Broth One-Step tubes because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.

    Product
    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V308000·2020-05-27

    Thor Motor Coach Recalls 2020 Motorhomes Due to Manual Error

    Thor Motor Coach is recalling 566 2020 motorhomes because the owner's manual incorrectly describes the automatic parking function, which could lead to vehicle rollaway.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR SIESTA, SYNERGY, GEMINI, DELANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Recall

    Becton Dickinson is recalling 1,262 Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1282-2020·2020-05-27

    West-Ward Recalls Ethacrynic Acid Tablets for Impurity Failures

    West-Ward Columbus Inc is recalling Ethacrynic Acid Tablets USP, 25 mg, because the product failed impurity and degradation specifications.

    Product
    Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2020·2020-05-27

    Becton Dickinson Recalls Bard MyPICC Kits Due to Gown Issue

    Becton Dickinson is recalling Bard MyPICC Kits because the included surgical gowns were subject to a supplier recall.

    Product
    BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
    Category
    Medical Device
    Distribution
    4 states
  • ModerateCPSC·20127·2020-05-27

    Primark Recalls Kitten Heel Court Shoes Due to Chromium Levels

    Primark is recalling Wide Fit Kitten Heel Court Pumps because the leather insoles contain elevated levels of Chromium VI, posing a risk of skin irritation.

    Product
    Wide Fit Kitten Heel Court Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2020·2020-05-27

    Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags

    Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.

    Product
    HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    Distributed nationwide