The Recall Desk

State

Indiana product recalls

73,366 recalls have nationwide distribution and so reach Indiana. 9,587 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,587
Critical
1,913
Severe
2,528
Most recent
2026-09-30

Of the 9,587 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,528 (26%) are Severe.

These figures cover only the 9,587 recalls whose distribution notice names Indiana specifically. The 73,366 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

19601–19625 of 82953

  • HighFDA (Devices)·Z-0491-2023·2022-12-21

    Stradis Healthcare Oral Surgery Trays Recalled Due to Incomplete Sealing

    Stradis Healthcare is recalling oral surgery trays due to incomplete outer bag sealing that may compromise the sterility of the surgical kit.

    Product
    STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2023·2022-12-21

    BASIC IMPLANT PACK Recalled for Incomplete Outer Bag Sealing

    Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.

    Product
    BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2023·2022-12-21

    FDA Class II Recall: DeRoyal BIOPSY PACK Medical Device

    DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.

    Product
    DeRoyal BIOPSY PACK, REF 89-9614.07
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0690-2023·2022-12-21

    FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices

    DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.

    Product
    DeRoyal CNRV SPINAL PACK, REF 89-10532.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0700-2023·2022-12-21

    DeRoyal medical device anesthesia pack Class II recall across 23 states

    DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.

    Product
    GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0523-2023·2022-12-21

    Procedure Trays Recalled for Potential Sterility Breach Due to Incomplete Sealing

    Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.

    Product
    HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2023·2022-12-21

    Medical procedure trays recalled for incomplete outer bag sealing

    Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.

    Product
    HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2023·2022-12-21

    Stradis Ablation Pack Recalled for Potentially Compromised Sterile Seal

    Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.

    Product
    STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2023·2022-12-21

    Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing

    HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Knee Pack, Item No.570-2908,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2023·2022-12-21

    Henry Schein Universal Tray Recall for Incomplete Sealing

    Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.

    Product
    HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)

    DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0512-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled for Incomplete Seal

    Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2023·2022-12-21

    Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit

    DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.

    Product
    DeRoyal TOTAL KNEE PACK, REF 89-9300.08
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0472-2023·2022-12-21

    Linear accelerator software addresses potential wrong-site treatment risk

    Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.

    Product
    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2023·2022-12-21

    Stradis Healthcare Medical and Surgical Trays Recalled for Incomplete Bag Sealing

    Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Lipo, Item No.681-254,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2023·2022-12-21

    Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack

    DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.

    Product
    DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0494-2023·2022-12-21

    Surgical Implant Trays Recalled for Incomplete Package Seal

    Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.

    Product
    Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2023·2022-12-21

    Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.

    Product
    STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2023·2022-12-21

    Stradis Healthcare catheter angiography kits recalled for defective sterile sealing

    Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.

    Product
    HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2023·2022-12-21

    Medical Surgical Trays and Kits Recalled for Incomplete Outer Bag Sealing

    Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.

    Product
    HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2023·2022-12-21

    Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect

    Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2023·2022-12-21

    Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing

    Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.

    Product
    STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2023·2022-12-21

    FDA Recalls DeRoyal HEART PACK Medical Device Kits

    FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.

    Product
    DeRoyal HEART PACK, REF 89-8351.13
    Category
    Medical Device
    Distribution
    23 states