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.

54401–54425 of 83431

  • HighFDA (Devices)·Z-1954-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.

    Product
    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16754·2016-06-22

    Ecovent Recalls Room Sensors Due to Electrical Shock Hazard

    Ecovent is recalling about 600 room sensors because the cover can come off, exposing high-voltage components and posing an electrical shock hazard.

    Product
    Ecovent room sensors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 438 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, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, 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
  • HighFDA (Devices)·Z-1969-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

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

    Product
    Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk During Blood Sampling

    Navilyst Medical is recalling 210 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 M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.

    Product
    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2016·2016-06-22

    Navilyst Medical Recalls Vaxcel PICC Catheters with PASV Valve

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

    Product
    Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

    Navilyst Medical is recalling 445 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, Maximal Barrier Nursing Kit, UPN H965750211 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-1991-2016·2016-06-22

    CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires

    CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.

    Product
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1952-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch sterile barrier system.

    Product
    TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 6.5 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-1955-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.

    Product
    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

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

    Product
    Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2016·2016-06-22

    Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.

    Product
    Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.

    Product
    BioSync Anatomic Cotton Wedge, 16 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-1998-2016·2016-06-22

    Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect

    Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 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-1962-2016·2016-06-22

    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 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-1953-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.

    Product
    TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

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

    Product
    Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 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-2000-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 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-1988-2016·2016-06-22

    Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology

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

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, 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-1951-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch barrier system.

    Product
    TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts may cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 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