State

Indiana product recalls

72,919 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.

Which agencies issued them

These figures cover only the 9,555 recalls whose distribution notice names Indiana specifically. The 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2276–2300 of 82474

HighFDA (Devices)·Z-1877-2026·2026-04-29
Medline Convenience Kits With Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2026·2026-04-29
AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2026·2026-04-29
Omega-3-Acid Ethyl Esters capsules recalled for failed capsule specifications
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
Product
OMEGA-3-ACID ETHYL ESTERS — OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1914-2026·2026-04-29
Arrow Pressure Injectable Central Venous Catheters Recalled
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1911-2026·2026-04-29
Arrow Radial Artery Catheterization Kit recalled for incorrect adhesive
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
Product
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)25121
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1926-2026·2026-04-29
Flamingo Funnel Large surgical smoke evacuation device recall
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Large, Model Number SQ20012-03
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1887-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes recalled for unapproved design changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2026·2026-04-29
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Product
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1880-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1846-2026·2026-04-29
Medline GYN Laparoscopy Pack regulatory clearance rescinded
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
Product
Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0521-2026·2026-04-29
Claravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
Product
CLARAVIS — CLARAVIS (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2026·2026-04-29
Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1840-2026·2026-04-29
Medline General Laparoscopy Kit regulatory clearance rescinded
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.
Product
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0667-2026·2026-04-29
Chips Ahoy Baked Bites Brookie recalled over hard corn starch lumps
CHIPS AHOY! Baked Bites Brookie cartons are being recalled because hard corn starch lumps were found in the product. 437 cases are affected.
Product
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Category
Food
Distribution
11 states
ModerateFDA (Devices)·Z-1829-2026·2026-04-29
Medline Namic Guidewires Recall Due to Rescinded FDA Clearance
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
Product
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1899-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2026·2026-04-29
Medline Namic Control Syringes recalled due to rescinded FDA clearance
Medline Industries is recalling Medline Namic Control Syringes (Model DYNJSYR10CWRB) because the FDA has rescinded their 510(k) regulatory clearance. The recall affects 24,170 units distributed nationwide.
Product
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1903-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1881-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L LAPAROTOMY PACK DYNJ46675G MAJOR LITHOTOMY PACK DYNJ81607 MAJ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1850-2026·2026-04-29
Medline Arthroscopy Pack regulatory clearance rescinded
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
Product
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1919-2026·2026-04-29
IV Administration Sets Potential Backflow and Occlusion Risk
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
Product
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1884-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design
Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1839-2026·2026-04-29
Medline ENT and Vascular Kits with Rescinded Regulatory Clearances
Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.
Product
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1917-2026·2026-04-29
Arrowgard Blue MAC Central Venous Access Kit recalled for defective adhesive
Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.
Product
Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term
Category
Medical Device
Distribution
Distributed nationwide