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.

5401–5425 of 76011

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-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-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-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-2511-2025·2025-09-10
MediHoney surgical adhesive sheets recalled over sterile barrier packaging failures
MediHoney HCS Surgical Adhesive Sheet dressings, catalog number 31738, lot 53824, are recalled after packaging failures were identified that could breach the sterile barrier. 4 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2509-2025·2025-09-10
MediHoney non-adhesive hydrogel dressings recalled over sterile barrier packaging failures
MediHoney Non-Adhesive Hydrogel Sheet Dressings, catalog numbers 31620 and 31640, are recalled after packaging failures were identified that could breach the sterile barrier. 5,374 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel ge
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V589000·2025-09-10
Volvo Recalls 2026 Models Due to Damaged Front Seat Belt Retractors
Volvo is recalling 2026 V60, V90, XC60, and XC90 models because damaged seat belt retractors may fail to restrain occupants in a crash.
Product
VOLVO — VOLVO V60CCMHEV, V90CCMHEV, XC60MHEV, redundant XC90MHEV
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2508-2025·2025-09-10
MediHoney hydrogel sheet dressings recalled over packaging failures compromising sterility
MediHoney Adhesive Hydrogel Sheet Dressings, catalog numbers 31720 and 31740, are recalled after packaging failures were identified that could breach the sterile barrier. 994 units are affected.
Product
Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combinat
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 (Drugs)·D-0608-2025·2025-09-10
Compounded semaglutide 0.8 mL vials recalled after testing subpotent
Semaglutide 2.5 mg/mL injection, 0.8 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 186 vials are affected.
Product
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2505-2025·2025-09-10
MediHoney paste tubes 31505 recalled over packaging failures affecting sterility
MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 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 environment con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0614-2025·2025-09-10
KIMMTRAK injection recalled after testing subpotent in three affected lots
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, is recalled nationwide as a subpotent drug. 7,572 vials are affected.
Product
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2025·2025-09-10
External fixation universal joints recalled because pins may become dislodged
Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.
Product
Medshape Universal Joints, REF: DNE-9000-UJ
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
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
ModerateFDA (Drugs)·D-0617-2025·2025-09-10
Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil
Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0615-2025·2025-09-10
Sulfamethoxazole and trimethoprim tablets recalled over micro-organism on packaging coil
Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2504-2025·2025-09-10
Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs
Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2516-2025·2025-09-10
Spinal implant inserters recalled over potential missing pins at the tip
TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2493-2025·2025-09-10
RayStation 12A planning software recalled over duplicate DICOM instance identifier risk
RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2514-2025·2025-09-10
Dental titanium bases recalled because the post is oriented 180 degrees off
NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2491-2025·2025-09-10
RayStation 11A planning software recalled over non-unique DICOM instance identifiers
RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2499-2025·2025-09-10
Defibrillator recalled because required post-service inspections were not performed
One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2492-2025·2025-09-10
RayStation 11B software recalled over non-unique DICOM instance identifiers
RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2490-2025·2025-09-10
RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique
RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide