State

Rhode Island product recalls

73,827 recalls have nationwide distribution and so reach Rhode Island. 3,054 additional recalls listed Rhode Island specifically in their distribution scope.

What the numbers show

Total: 3,054
Critical: 221
Severe: 708
Most recent: 2026-11-04

Of the 3,054 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 708 (23%) are Severe.

Which agencies issued them

These figures cover only the 3,054 recalls whose distribution notice names Rhode Island specifically. The 73,827 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

54926–54950 of 76881

HighFDA (Devices)·Z-2177-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2015·2015-07-29
ArthroCare Plasma Wand Devices Recalled for Dielectric Specification Failures
ArthroCare Corporation is recalling 733 EVac 70 XTRA and PROcise EZ View plasma wand devices because they were released without meeting dielectric specifications.
Product
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2015·2015-07-29
Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects
Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.
Product
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error
Perkinelmer is recalling two WIZARD2 gamma counters due to a barcode label error that may produce erroneous results.
Product
Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2015·2015-07-29
GE Healthcare Precision MPi Fluoroscopic Imaging Systems Recalled for Monitor Fall Risk
GE Healthcare is recalling Precision MPi fluoroscopic imaging systems because a monitor fell from its suspension, posing a risk of injury to patients or operators.
Product
GE Healthcare, Precision MPi fluoroscopic imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2015·2015-07-29
FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise
The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.
Product
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2015·2015-07-29
Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values
Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.
Product
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
Product
Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2015·2015-07-29
FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise
FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.
Product
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2160-2015·2015-07-29
FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2163-2015·2015-07-29
FDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues
American Medical Systems is recalling 16,710 Sure F!ex laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1254-2015·2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation
Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.
Product
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1260-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.
Product
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2172-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2098-2015·2015-07-29
CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error
CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.
Product
Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1276-2015·2015-07-29
Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate customer complaints.
Product
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2169-2015·2015-07-29
American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues
American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2148-2015·2015-07-29
EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure
EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.
Product
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1273-2015·2015-07-29
Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures
Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules because the firm did not adequately investigate customer complaints.
Product
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2181-2015·2015-07-29
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Product
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1258-2015·2015-07-29
Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation
Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.
Product
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1265-2015·2015-07-29
Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures
Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.
Product
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1269-2015·2015-07-29
Wockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation
Wockhardt USA is recalling specific lots of Lansoprazole Delayed-Release Capsules because the manufacturer did not adequately investigate customer complaints.
Product
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2127-2015·2015-07-29
Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error
Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.
Product
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1271-2015·2015-07-29
Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations
Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC…
Category
Drug
Distribution
Distributed nationwide