The Recall Desk

State

Indiana product recalls

73,833 recalls have nationwide distribution and so reach Indiana. 9,598 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total
9,598
Critical
1,908
Severe
2,536
Most recent
2026-11-04

Of the 9,598 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 2,536 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,598 recalls whose distribution notice names Indiana specifically. The 73,833 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

54426–54450 of 83431

  • HighFDA (Devices)·Z-1977-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling 328 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1959-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1987-2016·2016-06-22

    Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2016·2016-06-22

    Navilyst Medical Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 150 units of Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2016·2016-06-22

    Ethicon Recalls EVARREST Fibrin Sealant Patch Due to Labeling Error

    Ethicon is recalling 228 units of EVARREST Fibrin Sealant Patch because the expiration date field on the foil pouch labels contains the text '0-bad' instead of the valid date.

    Product
    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1983-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

    Navilyst Medical is recalling 376 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1989-2016·2016-06-22

    Excelsior Heparin Lock Flush Syringes Recalled for Potency Failure

    Excelsior Medical Corp is recalling specific lots of Heparin Lock Flush syringes because they failed potency testing.

    Product
    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1986-2016·2016-06-22

    Navilyst Medical Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 10 BioFlo Hybrid PICC catheter kits manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2016·2016-06-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Display Obstruction

    Physio-Control is recalling LIFEPAK 15 monitor/defibrillators with the EtCO2 feature because the respiratory rate display may obscure the leading digit of the EtCO2 value.

    Product
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2016·2016-06-22

    Valeant Recalls Mislabelled Lodrane D Capsules Due to Incorrect Ingredient Labeling

    Valeant Pharmaceuticals is recalling 3,827 bottles of Lodrane D capsules because the outer cartons were mislabeled with the wrong active ingredient.

    Product
    Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC 0 00950 86006 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2016·2016-06-22

    FSC Laboratories Recalls Flexichamber Holding Chambers Due to Seal Defects

    FSC Laboratories is recalling 1,435 Flexichamber Anti-Static Valved Collapsible Holding Chambers because the seal around the mouthpiece was torn or loose.

    Product
    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1030-2016·2016-06-22

    Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

    Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

    Product
    Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1038-2016·2016-06-22

    Par Pharmaceutical Recalls Pramipexole Dihydrochloride Extended Release Tablets

    Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because they contain a known impurity above approved specification levels.

    Product
    Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1994-2016·2016-06-22

    Anspach Universal Battery Charger II Recalled for Failure to Charge

    The Anspach Effort, Inc. is recalling 1,992 Universal Battery Charger II units because they enter safe mode and fail to charge batteries.

    Product
    Universal Battery Charger II (UBC II)
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1035-2016·2016-06-22

    Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities

    Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.

    Product
    Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1981-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters

    Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2001-2016·2016-06-22

    Natus neoBLUE Phototherapy System Recall for Warning Label Update

    Natus Medical is recalling 13,541 neoBLUE Phototherapy systems to add a warning statement to the instructions and provide a laminated Quick Guide for each device.

    Product
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1031-2016·2016-06-22

    Galderma Recalls Doxycycline Capsules Due to Missing Lot and Expiration Dates

    Galderma Laboratories is recalling Doxycycline USP Capsules 40 mg because some bottles are missing lot numbers or expiration dates.

    Product
    Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
    Category
    Drug
    Distribution
    Distributed nationwide