Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

17076–17100 of 27769

HighFDA (Devices)·Z-2228-2023·2023-08-02
Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.
Product
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0935-2023·2023-08-02
Oxacillin Injectable Recalled for Failure to Assure Sterility
Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.
Product
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1297-2023·2023-08-02
Zinc Sulfate Monohydrate ingredient recalled for potential lead contamination
Jost Chemical Co is recalling Zinc Sulfate Monohydrate, USP, because it may contain elevated levels of lead. This pharmaceutical ingredient was distributed to multiple countries including the United States.
Product
Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufacturing, Processing, or Repacking.
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-2239-2023·2023-08-02
Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk
Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.
Product
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2023·2023-08-02
Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard
Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.
Product
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2023·2023-08-02
Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency
New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.
Product
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2237-2023·2023-08-02
Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results
Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.
Product
Ringed DxI Reaction Vessels (RVs)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2230-2023·2023-08-02
Laser Fiber Devices May Overheat and Cause Burns During Use
Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.
Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2233-2023·2023-08-02
Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component
Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.
Product
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2023·2023-08-02
vRad PACS medical imaging system recalled for intermittent image display failures
Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.
Product
vRad PACS with Mammography
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2023·2023-08-02
Surgical mesh inflation malfunction in Ventralight ST hernia repair device
Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.
Product
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU On
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2238-2023·2023-08-02
FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length
The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.
Product
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1292-2023·2023-08-02
Spring Valley Potato Blintzes Recalled for Undeclared Milk
Spring Valley Potato Blintzes are being recalled because they contain undeclared milk. Consumers with milk allergies face health risks if they consume this product.
Product
SPRING VALLEY brand POTATO BLINTZES; NET WT. 13 OZ (369g); KEEP FROZEN; READY TO COOK; INGREDIENTS: WHEAT FLOUR (WHET FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVEN, ENZYME, FOLIC ACID), WATER, POTATOES, EGG, ONIONS, CANOLA OIL, EGG WHITES, DEXTROSE, CORN STARCH, SA
Category
Food
Distribution
4 states
HighFDA (Drugs)·D-0936-2023·2023-08-02
Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
Product
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2023·2023-08-02
Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2243-2023·2023-08-02
Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery
A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.
Product
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2215-2023·2023-08-02
Respiratory diagnostic panel fails to produce test results
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.
Product
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapn
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2234-2023·2023-08-02
Laser fiber medical devices recalled for potential burn injury hazard
Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.
Product
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2023·2023-08-02
Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component
Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.
Product
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2023·2023-08-02
Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard
Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.
Product
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2023·2023-08-02
Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.
Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2023·2023-08-02
Trexo Device recalled due to electrical hazards and burn risk
Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.
Product
Trexo Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2023·2023-08-02
Hernia repair mesh balloon may not inflate during surgery
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
Product
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0945-2023·2023-08-02
SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations
SCA Pharmaceuticals is recalling 183 bags of a fentanyl-bupivacaine injectable due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed to Kentucky and New Jersey.
Product
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0937-2023·2023-08-02
Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.
Product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide

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17076–17100 of 27769