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

8401–8425 of 13652

ModerateFDA (Devices)·Z-2535-2023·2023-09-20
Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2581-2023·2023-09-20
Welch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement
Baxter Healthcare is recalling the Welch Allyn Connex Spot Monitor due to improper placement of copper tape on the back of the liquid-crystal display. The device was distributed in California.
Product
Welch Allyn Connex Spot Monitor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2579-2023·2023-09-20
Copaliner Cavity Varnish Recalled for Solvent Mislabeling Error
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
Product
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2517-2023·2023-09-13
Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect
Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.
Product
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2518-2023·2023-09-13
Trocar with oversized shaft obscures surgical view in brain operations
Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.
Product
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2522-2023·2023-09-13
Olympus Distal Attachment Recalled for Phthalate Exceeding Permissible Levels
Aomori Olympus Co., Ltd. recalls 1,048 Olympus Distal Attachment units used in EMR kits due to di-2-ethylhexyl phthalate (DEHP) exceeding permissible exposure limits per ISO 10993-17: 2002. Devices were distributed nationwide.
Product
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2404-2023·2023-09-13
Medical Imaging System Recalled for Foot Pedal Malfunction Risk
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Product
MultiDiagnost-Eleva
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2023·2023-09-13
Reusable Endoscopy Distal Attachments Recalled for Excessive DEHP Levels
Aomori Olympus recalls 1,252 reusable distal attachment devices with DEHP chemical levels exceeding safe exposure limits per medical device standards. Devices distributed nationwide in the United States.
Product
Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2403-2023·2023-09-13
Azurion imaging systems recalled for stuck foot switch causing unintended radiation
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.
Product
Azurion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2519-2023·2023-09-13
Hip Prosthesis Implants Recalled for Size Mismatch Between Label and Device
Zimmer, Inc. is recalling M/L Taper Hip Prosthesis implants where the outer package labeling and product etch do not match the actual implant size. This mislabeling could lead to implantation of the wrong-sized prosthesis.
Product
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2023·2023-09-13
Fargo Ortho-K Contact Lens Recall Due to Missing FDA Approval
PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.
Product
Fargo Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2023·2023-09-13
Cook Lead Clipper Cardiac Device Sterility Recall Due to Packaging Defect
Cook Vandergrift is recalling approximately 15,951 Cook Lead Clipper devices due to potential sterility compromise from packaging seal breaches. The surgical tool is used for cardiac lead retrieval procedures.
Product
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2515-2023·2023-09-13
ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval
Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.
Product
ISee Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2402-2023·2023-09-13
Philips Allura Xper X-ray Systems Foot Pedal May Stick, Causing Unintended Radiation
Philips Allura Xper X-ray imaging systems are being recalled because the foot switch pedal may become stuck in the active position, potentially causing unintended radiation emission. The recall affects 5,432 systems distributed nationwide.
Product
Allura Xper series
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2521-2023·2023-09-13
ZVU Functional GI Software Recall for Incorrect Software Revision Labeling
ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.
Product
ZVU Functional GI Software, REF: ZVU-3
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2438-2023·2023-09-06
Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2431-2023·2023-09-06
Cardiosave Hybrid Intra-Aortic Balloon Pump charging issue recall
The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2434-2023·2023-09-06
Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2433-2023·2023-09-06
Cardiosave Hybrid IABP devices recalled for temperature and pumping function failures
Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2436-2023·2023-09-06
Cardiosave Rescue IABP Alarms May Trigger Unexpectedly During Therapy
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2437-2023·2023-09-06
Cardiosave Hybrid Intra-Aortic Balloon Pumps recalled for autofill failure
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2435-2023·2023-09-06
Intra-Aortic Balloon Pumps recalled for unexpected gas loss and gain alarms
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2467-2023·2023-09-06
EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2432-2023·2023-09-06
Cardiosave Rescue Intra-Aortic Balloon Pumps Fail to Charge When Improperly Inserted
Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2481-2023·2023-09-06
Surgical Rasp Handle May Fracture Due to Weld Crack
The Link OptiStem Rasp Handle used in knee replacement surgery may develop a crack in the weld that causes the handle to fracture. If this occurs, surgical removal of the rasp must be modified, potentially prolonging the procedure.
Product
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Category
Medical Device
Distribution
3 states

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8401–8425 of 13652