State

Rhode Island product recalls

72,968 recalls have nationwide distribution and so reach Rhode Island. 3,043 additional recalls listed Rhode Island specifically in their distribution scope.

What the numbers show

Total: 3,043
Critical: 221
Severe: 570
Most recent: 2026-09-09

Of the 3,043 recalls naming Rhode Island we have scored against our rubric, 221 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 570 (19%) are Severe.

Which agencies issued them

These figures cover only the 3,043 recalls whose distribution notice names Rhode Island specifically. The 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5376–5400 of 76011

CriticalFDA (Devices)·Z-2449-2025·2025-09-10
Dexcom ONE+ Android app recalled over missing sensor failure alerts
The Dexcom ONE+ Android CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 41,629 units are affected.
Product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monit
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2482-2025·2025-09-10
Left heart vent catheters recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0613-2025·2025-09-10
Health care antiseptic recalled over contamination with Burkholderia cepacia bacteria
DermaRite PeriGiene Health Care Antiseptic containing chloroxylenol 0.5% is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
Product
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2455-2025·2025-09-10
Multi Joystick wheelchair controls recalled over unintended movement at power-up
Multi Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.
Product
Multi Joystick R-net. Electrical wheelchair component.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2480-2025·2025-09-10
Left heart vent catheters 13FR recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0610-2025·2025-09-10
Antiseptic lotion soap recalled over contamination with Burkholderia cepacia
DermaRite DermaKleen Health Care Antiseptic Lotion Soap is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 11,321 bag-in-boxes are affected.
Product
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2447-2025·2025-09-10
Dexcom G7 iOS app recalled because sensor failure alerts do not appear
The Dexcom G7 CGM iOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0611-2025·2025-09-10
External analgesic lotion recalled over Burkholderia cepacia contamination
DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.
Product
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2446-2025·2025-09-10
Glucose monitor apps recalled because sensor failed alerts do not appear
Dexcom G7 and ONE+ CGM apps are recalled because the app does not give the expected Sensor Failed alert, instead silently ending the session. The FDA classified the action as Class I. 532,821 units are affected.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitor
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2450-2025·2025-09-10
Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear
The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.
Product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Sys
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2459-2025·2025-09-10
IDM-ARLITE-R wheelchair controls recalled over unintended movement on power-up
IDM-ARLITE-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 25 units are affected.
Product
IDM-ARLITE-R. Electrical wheelchair component.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2448-2025·2025-09-10
Dexcom G7 watchOS app recalled because sensor failure alerts are missing
The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2456-2025·2025-09-10
IDM-MICRO-R wheelchair controls recalled over unintended movement on power-up
IDM-MICRO-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.
Product
IDM-MICRO-R. Electrical wheelchair component.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0627-2025·2025-09-10
Lactated Ringer's injection containers recalled over presence of particulate matter
B. Braun Lactated Ringer's Injection USP in 1000 mL containers, lot J4S807, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 46,032 containers are affected.
Product
LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2481-2025·2025-09-10
Left heart vent catheters 10FR recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12110, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 41,200 units are affected.
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0612-2025·2025-09-10
Antimicrobial foam soap recalled over contamination with Burkholderia cepacia
DermaRite KleenFoam Antimicrobial Foam Soap with Aloe Vera is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I. 6,973 cartridges are affected.
Product
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·25V590000·2025-09-10
Harley-Davidson Sportster S motorcycles recalled because upper triple clamp may fracture
Harley-Davidson is recalling certain RH1250S Sportster S motorcycles because the upper triple clamp may fracture, which could cause a loss of control. 8,424 units are potentially affected.
Product
HARLEY-DAVIDSON — HARLEY-DAVIDSON RH1250S
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2506-2025·2025-09-10
MediHoney paste tubes recalled over packaging failures breaching the sterile barrier
MediHoney Paste tubes, catalog numbers 31515 and 31535, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 141,620 units are affected.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist envir
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2025·2025-09-10
Surgical drape packs recalled because open seals may compromise sterility
Orthopedic Pack model 88041-12 and Universal Pack model 77165-06 are recalled because the surgical drape packs may have open seals that could compromise sterility. 1,316 units are affected.
Product
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2507-2025·2025-09-10
MediHoney HCS sheet dressings recalled over packaging failures breaching sterility
MediHoney HCS Sheet Dressings, catalog numbers 31612, 31622 and 31644, are recalled after packaging failures were identified that could breach the sterile barrier. 3,583 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination w
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2510-2025·2025-09-10
MediHoney hydrogel adhesive sheets recalled over sterile barrier packaging failures
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2502-2025·2025-09-10
Azurion imaging systems recalled because single phase UPS may fail on power loss
Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.
Product
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2486-2025·2025-09-10
Radiotherapy systems recalled over software allowing more than two daily fractions
RefleXion X1 systems are recalled because an incorrect software configuration potentially allows more than two treatment fractions within a 12-hour period, which could lead to toxicity. 11 units are affected.
Product
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2519-2025·2025-09-10
Sterile cover kits recalled because elastic bands may detach during surgery
Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.
Product
Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Version: Not Applicable Product Description: Sterile Cover
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2025·2025-09-10
Spinal decompression implants recalled after review found instrument and device breakage
Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.
Product
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
Category
Medical Device
Distribution
Distributed nationwide