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

7301–7325 of 27364

HighFDA (Devices)·Z-2347-2023·2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments May Require Increased Removal Force
LINK MP Monoblock Hip Stem trial instruments may require increased force to remove after impaction, potentially prolonging surgery for affected patients.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2358-2023·2023-08-16
FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators because reagent packs may contain incorrect wells that could produce false negative results. The recall affects 4,013 units distributed worldwide.
Product
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2361-2023·2023-08-16
Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors
Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.
Product
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2356-2023·2023-08-16
LINK MP Monoblock Hip Stem Trial Instruments Difficult to Remove After Impaction
Waldemar Link is recalling LINK MP Monoblock Hip Stem trial instruments because they may require increased force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2394-2023·2023-08-16
HoverMatt air transfer mattress contains undersized unit, increases injury risk
Stryker's HoverMatt 39-inch inflatable transfer mattresses contain 34-inch units inside, reducing available support surface. This increases friction during patient transfers and raises the risk of skin tears.
Product
HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2397-2023·2023-08-16
Philips MR 7700 Magnetic Resonance System Smoke Detector Interlock Bypass
Philips MR 7700 MRI systems can have their smoke detector interlock safety mechanism bypassed when power cycled after smoke detection, allowing continued operation despite potential fire hazards.
Product
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2364-2023·2023-08-16
Medical Device Recall: UroLift Visual Obturator Weld Defect Risk
The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.
Product
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2393-2023·2023-08-16
Ellacor System recalled for bearing adhesive defect risk
The FDA is recalling 127 Ellacor System devices for a potential bearing adhesive failure in the handpiece. The defect could cause core overlap, leading to prolonged healing and scarring.
Product
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2396-2023·2023-08-16
Ingenia Elition S MR System smoke detection interlock vulnerable to operator bypass
Philips Ingenia Elition S MR systems can be circumvented by power cycling to bypass the smoke detection safety interlock that locks after smoke is detected. This could allow continued operation despite fire hazards.
Product
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2023·2023-08-16
Hip Stem Trial Implant May Require Excessive Force During Removal
A trial hip stem implant may require excessive force to remove after insertion during surgery, potentially prolonging the procedure or requiring surgical modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2023·2023-08-16
LINK MP Hip Stem trial instruments may require increased removal force during surgery
LINK MP Monoblock hip stem trial instruments may require increased force to remove during surgery, potentially prolonging procedures or requiring surgical modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2350-2023·2023-08-16
Hip stem trial instruments recalled due to excessive removal force
LINK MP Monoblock hip stem trial instruments may require excessive force to remove after impaction, potentially prolonging surgery or requiring procedural modification.
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2359-2023·2023-08-16
Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect
Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical procedures.
Product
ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
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-2286-2023·2023-08-09
Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk
Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility defect
Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYN
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-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-2311-2023·2023-08-09
Procedural Kits Containing Ultrasound Gel Recalled for Sterility Concerns
Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2307-2023·2023-08-09
Medline Procedural Kits with Turkuaz Ultrasound Gel Recalled for Sterility Concerns
Medline is recalling custom sterile procedural kits containing Turkuaz ultrasound gel due to potential sterility specification failures. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2023·2023-08-09
STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk
FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2323-2023·2023-08-09
Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements
Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2275-2023·2023-08-09
OEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
GE OEC Medical Systems is recalling two OEC Flexiview 8800 fluoroscopic imaging systems due to image intensifiers that may detach and fall during movement, potentially causing fractures, hematoma, contusion, bruise, or pain.
Product
OEC Flexiview 8800 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2023·2023-08-09
Medline Pediatric EP Pack Procedural Kits with Sterile Ultrasound Gel Defect
Medline is recalling pediatric electrophysiology procedural kits because the ultrasound gel component may not meet sterility specifications. The recall affects 192 kits distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
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

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7301–7325 of 27364