State

Indiana product recalls

73,106 recalls have nationwide distribution and so reach Indiana. 9,585 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,585
Critical: 1,913
Severe: 2,148
Most recent: 2026-09-23

Of the 9,585 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,148 (22%) are Severe.

Which agencies issued them

These figures cover only the 9,585 recalls whose distribution notice names Indiana specifically. The 73,106 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

12676–12700 of 82691

HighFDA (Devices)·Z-1434-2024·2024-04-10
Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach
Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.
Product
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2024·2024-04-10
Centurion Scalpel Handles Recalled Due to Weak Seal Risk
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
Product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Implants Recalled for Nonconforming Packaging
Exactech is recalling 826 Equinoxe Reverse Shoulder humeral liners (Item Numbers 320-36-10 and 320-36-13) due to nonconforming packaging. The vacuum bags lack the required oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Product
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2024·2024-04-10
Mobile X-ray System Structural Cable Defect Affects Safety Function
Agfa DX-D 100 mobile X-ray systems have a structural cable defect in the support column that may prevent the safety mechanism from blocking the arm if the cable fails, potentially resulting in patient injury.
Product
Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2024·2024-04-10
Suture Removal and Staple Remover Kits Recalled for Weak Seal
Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.
Product
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1447-2024·2024-04-10
Centurion PICC Line Securement Kit Recalled for Weak Seal
MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.
Product
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2024·2024-04-10
Exactech Equinoxe Shoulder Glenoid Components Recalled for Defective Packaging
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2024·2024-04-10
Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
Product
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2024·2024-04-10
Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
Product
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2024·2024-04-10
ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.
Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2024·2024-04-10
Covidien Auto Suture blunt tip trocar recalled for seal disengagement
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
Product
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2024·2024-04-10
Centurion Manual Uterine Dilator Surgical Kits Recalled for Weak Seal
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2024·2024-04-10
Medline Alcohol Swabsticks Recalled for Weak Seal Compromising Sterility
Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
Product
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2024·2024-04-10
Exactech Equinoxe Glenoid Shoulder Components Recalled for Nonconforming Packaging
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2024·2024-04-10
Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation
FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.
Product
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1454-2024·2024-04-10
Medline wire cut scissors may have weak seal compromising sterility
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Product
MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2024·2024-04-10
Medline Swabsticks PVP Product Recalled for Weak Seal Risk
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Product
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2024·2024-04-10
Medline Pediatric Magill Catheter Recalled for Weak Seal Risk
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Product
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2024·2024-04-10
BD Phoenix diagnostic panel recalled for drug cross-contamination
Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.
Product
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2024·2024-04-10
Centurion Curette kits recalled for weak seals potentially compromising sterility
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
Product
Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2024·2024-04-10
Skull Anchor Key Defect Prevents CT Localizer Attachment
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2024·2024-04-10
Medline Centurion Surgical Forceps Kits Recalled for Defective Seals
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Product
Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1424-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
Product
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0432-2024·2024-04-10
Fentanyl Citrate Injectable Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
Product
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2024·2024-04-10
Centurion Surgical Hook Kits Recalled Due to Weak Seal
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
Product
Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Category
Medical Device
Distribution
Distributed nationwide