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

9401–9425 of 40095

HighFDA (Devices)·Z-2355-2023·2023-08-16
LINK MP Hip Stem Trial Instruments difficult to remove after implantation
The LINK MP Monoblock hip stem trial instruments may require increased force to remove after implantation, potentially prolonging surgery or requiring modification of the surgical procedure.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2362-2023·2023-08-16
Randox Urea Enzymatic Assay Recall: Falsely Low Test Results Risk
FDA recalls Randox RX Series Urea test kits because carryover from prior LDL-cholesterol tests may produce falsely low results, up to 11% below accurate values, potentially delaying diagnosis.
Product
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2343-2023·2023-08-16
Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility
Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.
Product
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2349-2023·2023-08-16
Hip Stem Trial Instrument Difficult to Remove After Impaction
LINK MP Monoblock hip stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery or requiring procedure modification. No injuries or illnesses have been reported.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2400-2023·2023-08-16
MR 7700 Magnetic Resonance System Diagnostic Cable Installation Defect
Philips MR 7700 Magnetic Resonance systems may have an improperly installed diagnostic cable. The cable does not impact system functionality or patient safety.
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2392-2023·2023-08-16
Canon Medical INFX-8000C Tableside Console PWB Requires Replacement
Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.
Product
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2398-2023·2023-08-16
Philips Ingenia Elition X MR Systems Diagnostic Cable Installation Issue
Philips is recalling 601 Ingenia Elition X MR systems because a diagnostic cable may not have been properly installed, though system operation is not affected.
Product
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2365-2023·2023-08-16
Medtronic InterStim Ground Pad Recalled for Incorrect Expiration Date Label
Medtronic is recalling InterStim Self-Adhesive Ground Pad (lot 60347246) due to incorrect expiration date labeling. Affected units were distributed internationally including to Iran.
Product
Medtronic InterStim Ground Pad REF 041826
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2363-2023·2023-08-16
Surgical Spinal Tap Device Recalled for Incorrect Laser Marking
Medtronic is recalling Solera Awl Tip Tap surgical devices due to incorrect laser marking. Thirteen devices were distributed in Florida, Colorado, Indiana, South Carolina, Texas, and Utah.
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2399-2023·2023-08-16
MRI System Cable Installation Issue During Service Setup
Philips Ingenia Elition S MR systems may have an improperly installed cable connecting the SmokeDetector Interlock to the host PC. This affects service diagnostics only and does not impact system functionality.
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2353-2023·2023-08-16
LINK MP Hip Stem Difficult to Remove After Surgical Implantation
Waldemar Link is recalling LINK MP Monoblock hip stem prosthetics that may require increased force to remove after surgical implantation, potentially prolonging surgery.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2023·2023-08-09
Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2023·2023-08-09
NanoZoomer S360MD Slide Scanner May Record Incorrect Barcode Information
Hamamatsu's NanoZoomer S360MD slide scanner may record incorrect barcode information in the NDPi file, potentially causing pathologists to reference the wrong patient's digital slide image.
Product
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2260-2023·2023-08-09
Philips Incisive CT Scanner Mounting Box Poses Injury Risk
A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.
Product
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2334-2023·2023-08-09
Medline sterile procedural kits recalled for potential sterility specification failures
Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2023·2023-08-09
Philips CT scanner heat exchanger box may detach and cause injury
The metal mounting box on the rotating scanner of the Incisive CT system may become detached and contact other components, potentially injuring users or causing system shutdown.
Product
Incisive CT-Computed Tomography X-Ray System Model: 728143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2319-2023·2023-08-09
Medline sterile procedural kits recalled for potentially non-sterile gel
Medline is recalling 83,541 procedural kits because the included ultrasound gel component may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2023·2023-08-09
Medline procedural kits with potentially non-sterile ultrasound gel recalled
Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2312-2023·2023-08-09
Surgical Procedural Kits Recalled for Potential Sterility Specification Failures
Medline Industries is recalling 16,143 custom surgical procedural kits because the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2325-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure
Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2324-2023·2023-08-09
Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Num
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2316-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
Medline is recalling 6,733 custom procedural kits due to potential sterility failure in the Turkuaz ultrasound gel component. The gel may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC PACK, Model Number: DYNJ46967F; b. ENDOVENOUS ABLATION PACK, Model Number: DYNJ64059; c. ENDOVENOUS CORE PACK: DYNJ62557; d. TVS4000 ENDOVENOUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2269-2023·2023-08-09
SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction
Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2326-2023·2023-08-09
FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure
Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Mode
Category
Medical Device
Distribution
Distributed nationwide

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9401–9425 of 40095