The Recall Desk

State

Indiana product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5051–5075 of 82495

  • HighFDA (Devices)·Z-0183-2026·2025-10-22

    Spine and laminectomy packs recalled after being sterilized more than once

    American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2026·2025-10-22

    Gynecology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling gynecology, laparoscopy and hysteroscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2026·2025-10-22

    TENACIO pumps with InhibiZone recalled over inflation and deflation issues

    Boston Scientific is recalling 59 TENACIO Pump with InhibiZone units, UPN 72404429, because of the potential for inflation or deflation performance issues or difficulties.

    Product
    TENACIO Pump with InhibiZone; UPN: 72404429;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

    American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2026·2025-10-22

    Angiography procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2026·2025-10-22

    Monitor display cables recalled over inadequate shielding and electromagnetic interference

    Spacelabs Healthcare is recalling 16,898 DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2026·2025-10-22

    Radiology procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2026·2025-10-22

    Shoulder surgical planning software recalled over possible implant malalignment risk

    Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.

    Product
    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2026·2025-10-22

    Preconnect pump devices recalled over inflation and deflation performance issues

    Boston Scientific is recalling 172 CXR Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2026·2025-10-22

    Dilation and curettage packs recalled after being sterilized more than once

    American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits IHDC30R D AND C PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2026·2025-10-22

    Twelve foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2026·2025-10-22

    Omnipod 5 app recalled because magnifying a field duplicates typed digits

    Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.

    Product
    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2026·2025-10-22

    LGX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2026·2025-10-22

    Filtered extension sets recalled across two lots because IV sets may leak

    Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.

    Product
    CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2026·2025-10-22

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2026·2025-10-22

    Hydromorphone syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Hydromorphone HCL PF 10mg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2026·2025-10-22

    Ketamine syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling one lot of Ketamine Hydrochloride 50mg/5 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2026·2025-10-22

    Everolimus tablets recalled for out of specification impurity in one lot

    Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.

    Product
    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2026·2025-10-22

    Fentanyl citrate syringes recalled over incorrect or missing lot and expiry

    STAQ Pharma is recalling three lots of FentaNYL Citrate PF 500mcg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.

    Product
    FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
    Category
    Drug
    Distribution
    Distributed nationwide