State

Indiana product recalls

73,817 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 73,817 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

44201–44225 of 83415

ModerateFDA (Devices)·Z-0928-2018·2018-03-14
Medtronic O-arm 1000 X-ray System Software Update Recall
Medtronic is recalling 253 O-arm 1000 mobile X-ray systems to implement a software update that resolves multiple operational and imaging defects.
Product
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0882-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0726-2018·2018-03-14
NeuroLogica GC80 Digital X-ray Imaging System Recalled for Overexposure
NeuroLogica Corporation is recalling 45 units of the GC80 Digital X-ray Imaging System because images obtained during examinations may be overexposed.
Product
The GC80 Digital X-ray Imaging System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0914-2018·2018-03-14
Ortho-Clinical VITROS Performance Verifier IV Recall for Storage Labeling
Ortho-Clinical Diagnostics is recalling 196 units of VITROS Chemistry Products DAT Performance Verifier IV because storage labeling errors may cause lower than expected test results.
Product
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0894-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0887-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0916-2018·2018-03-14
Stryker Reprocessed EP Catheters Recalled for EEPROM Chip Error
Stryker is recalling 170 reprocessed EP catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
Product
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0917-2018·2018-03-14
Stryker Recalls Reprocessed EP Catheters Due to Navigation System Error
Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
Product
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0869-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0879-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0881-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0877-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0893-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7603G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0861-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0929-2018·2018-03-14
Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to False Positives
Euro Diagnostica is recalling 1,090 units of DIASTAT ANA ELISA kits because high background levels may cause false positive test results.
Product
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0926-2018·2018-03-14
Abbott i-STAT DE Handheld Module Software Update Recall
Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.
Product
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-0890-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0874-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0576-2018·2018-03-14
Hospira Recalls Labetalol Hydrochloride Injection Due to Cracked Glass Vials
Hospira Inc. is recalling Labetalol Hydrochloride Injection vials because of cracked glass at the rim, which is covered by the stopper and crimp seal.
Product
LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0866-2018·2018-03-14
Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.
Product
LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0891-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0915-2018·2018-03-14
Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues
Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.
Product
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0889-2018·2018-03-14
Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery because of an atypical volume of complaints regarding dull blades.
Product
LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0895-2018·2018-03-14
Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues
Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.
Product
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Category
Medical Device
Distribution
Distributed nationwide