The Recall Desk

State

Indiana product recalls

20,199 recalls have nationwide distribution and so reach Indiana. 0 additional recalls listed Indiana specifically in their distribution scope.

About recalls in Indiana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Indiana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

9601–9625 of 20199

  • HighFDA (Devices)·Z-1438-2024·2024-04-10

    Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk

    Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.

    Product
    Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2024·2024-04-10

    Covidien Auto Suture blunt tip trocar recalled for seal disengagement

    Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2024·2024-04-10

    Medline Swabsticks PVP Product Recalled for Weak Seal Risk

    Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.

    Product
    MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2024·2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2024·2024-04-10

    Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging

    Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.

    Product
    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1410-2024·2024-04-10

    Exactech Shoulder Implants Recalled for Improper Packaging Defect

    Exactech Equinoxe glenoid shoulder implants were packaged with non-conforming bags lacking an oxygen barrier layer (EVOH), creating potential risk of material degradation. The Class II recall affects 180 units distributed nationwide and internationally.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2024·2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2024·2024-04-10

    Centurion Sterile Trach Brush Recalled Due to Weak Seal

    Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.

    Product
    Centurion STERILE TRACH BRUSH, Product Code 6225ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1414-2024·2024-04-10

    Exactech Equinoxe Shoulder Components Recalled for Nonconforming Packaging

    Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0433-2024·2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.

    Product
    Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2024·2024-04-10

    BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement

    Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.

    Product
    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2024·2024-04-10

    Shoulder Implant Components Recalled for Nonconforming Packaging

    Exactech Inc. is recalling 11,031 shoulder implant components due to nonconforming vacuum bag packaging lacking a required oxygen barrier layer. The missing Ethylene Vinyl Alcohol (EVOH) layer could allow oxygen exposure to the UHMWPE material.

    Product
    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 24,303 units of Equinoxe Reverse Shoulder humeral liners due to nonconforming vacuum-bag packaging. The bags lack the required oxygen barrier layer, failing to meet packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1413-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 12,643 units of Equinoxe CAGE GLENOID shoulder implants because packaging lacks a required oxygen barrier layer. Units were vacuum-sealed without the proper Ethylene Vinyl Alcohol (EVOH) barrier.

    Product
    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1404-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging

    Exactech Inc. is recalling 6,678 shoulder glenoid implant components because they were packaged in vacuum bags lacking the required oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).

    Product
    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2024·2024-04-10

    Exactech Equinoxe Shoulder Arthroplasty Liner Recalled for Nonconforming Packaging

    Exactech recalls 447 units of Equinoxe Constrained Humeral Liner due to nonconforming packaging lacking required oxygen barrier layer (EVOH). Affected units were distributed nationwide and internationally.

    Product
    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0434-2024·2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.

    Product
    Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1409-2024·2024-04-10

    Exactech Equinoxe Shoulder Arthroplasty Components Recalled for Defective Packaging

    Exactech recalls 39 UHMWPE shoulder arthroplasty components due to nonconforming vacuum packaging that lacks the required oxygen barrier layer.

    Product
    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1474-2024·2024-04-10

    Karl Storz Uvula Retractors Recalled for Inadequate Reprocessing Validation

    Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor due to inadequate reprocessing validation. The manufacturer cannot demonstrate that current sterilization methods ensure proper device sterility.

    Product
    Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1400-2024·2024-04-10

    Hill-Rom PRO+ Pressure Relief Mattress Service Correction Reassessment

    Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.

    Product
    Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Implant Liners Recalled for Oxygen Barrier Packaging Defect

    Exactech recalls 3,648 reverse shoulder implant liners due to nonconforming packaging. Vacuum bags lack required oxygen barrier (EVOH) protection against material degradation.

    Product
    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2024·2024-04-10

    X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall

    X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.

    Product
    X-Guide Handpiece Adaptor Sleeve 3, Model P010727
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1475-2024·2024-04-10

    3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects

    3M is recalling 265,435 tube securement devices (REF 1500U and 1501U) due to manufacturing defects including missing or partial top film layers and incorrect device shape from excess material not properly removed.

    Product
    3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1420-2024·2024-04-10

    Exactech Equinoxe Humeral Liner Shoulder Implant Recalled for Nonconforming Packaging

    Exactech Equinoxe Humeral Liners used in shoulder surgery are being recalled due to nonconforming packaging. Approximately 2,806 units lack the required oxygen barrier layer in their vacuum-bag packaging.

    Product
    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2024·2024-04-10

    Halyard surgical hood mislabeled as surgical cap at dispenser

    O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.

    Product
    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
    Category
    Medical Device
    Distribution
    Distributed nationwide