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.

53526–53550 of 83431

HighFDA (Devices)·Z-2292-2016·2016-08-03
Zimmer Avenir Moller Hip Stem Recall Due to Packaging Mix-up
Zimmer GmbH is recalling two Avenir Moller hip stem models due to a packaging mix-up that could lead to the use of the incorrect implant.
Product
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2016·2016-08-03
Beckman Coulter Allegra X-5 Rotor Yoke Recalled for Defect
Beckman Coulter is recalling Allegra X-5 rotor yokes because a defect allows improper rotor seating, which could lead to rotor failure if buckets are loaded in an imbalanced configuration.
Product
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2016·2016-08-03
Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk
Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.
Product
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2283-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling
LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they could be used for dura closure.
Product
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1450-2016·2016-08-03
Sagent Pharmaceuticals Recalls Oxacillin for Injection Due to Particulate Matter
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to the presence of small, dark particulate matter in the solution after reconstitution.
Product
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2279-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use in the United States.
Product
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2287-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 39 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
Product
AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2297-2016·2016-08-03
Smith & Nephew Recalls Spherical Head Reflection Cancellous Screws Due to Labeling Error
Smith & Nephew is recalling 185 units of Spherical Head Reflection 6.5 mm Cancellous Screws because the packaging contained 35mm screws instead of the labeled 25mm size.
Product
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2299-2016·2016-08-03
Siemens Recalls Theophylline Reagent Due to Increased Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Theophylline reagents because they may exhibit increased imprecision when used with certain quality control materials.
Product
ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. Copies of IFUs included in submission.
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2298-2016·2016-08-03
Siemens Syva EMIT 2000 Theophylline Reagent Recall for Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Syva EMIT 2000 Theophylline reagents due to potential increased imprecision when used with certain quality control materials.
Product
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-2251-2016·2016-08-03
Best Theratronics Cabinet X-Ray Systems Recalled for Performance Non-Compliance
Best Theratronics is recalling 128 cabinet x-ray systems used to irradiate blood products because they failed to comply with performance standards.
Product
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2284-2016·2016-08-03
LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling
LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested they could be used for dura closure.
Product
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2289-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.
Product
AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1449-2016·2016-08-03
Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications
Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.
Product
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1448-2016·2016-08-03
Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Actavis Inc is recalling Dextroamphetamine Sulfate Extended-Release Capsules because they failed to meet dissolution specifications. The recall covers 8,062 units distributed nationwide.
Product
DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2275-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2276-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.
Product
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2277-2016·2016-08-03
Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
Product
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2288-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
Product
AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2286-2016·2016-08-03
LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.
Product
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2285-2016·2016-08-03
LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling
LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System because marketing materials incorrectly stated the device could be used for dura closure.
Product
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1451-2016·2016-08-03
Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels
Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.
Product
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2282-2016·2016-08-03
Tosoh Bioscience Recalls Progesterone 3 Calibrator Sets Due to Incorrect IFU Lot Number
Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.
Product
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Category
Medical Device
Distribution
Distributed nationwide