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 the agency’s own highest classification or reported deaths or serious injuries, 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

18501–18525 of 27682

HighFDA (Devices)·Z-1103-2018·2018-03-28
Boston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets
Boston Scientific is recalling specific Re-Entry Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.
Product
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1137-2018·2018-03-28
ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk
ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat in certain settings.
Product
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1094-2018·2018-03-28
Centurion Infant IV Securement Kit Recalled by FDA
Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.
Product
INFANT IV SECUREMENT KIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1134-2018·2018-03-28
Medfusion Syringe Pumps Recalled for Syringe Misidentification Risk
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.
Product
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2018·2018-03-28
Bovie Medical Recalls J-Plasma Handpieces Due to Incomplete Cable Seal
Bovie Medical is recalling 5,416 J-Plasma handpieces worldwide because an incomplete cable seal could allow patient fluid backflow, creating a cross-contamination risk.
Product
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1097-2018·2018-03-28
Centurion Medical Products Recalls Wound Care Kits
Centurion Medical Products Corporation is recalling Wound Care Kits due to a Class II medical device recall. The kits are intended to assist practitioners with IV placement and securement.
Product
WOUND CARE KIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1099-2018·2018-03-28
Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage
Boston Scientific is recalling 422 units of Malecot Nephrostomy Catheters because they may break at the mid-shaft bond during use.
Product
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1138-2018·2018-03-28
ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk
ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.
Product
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1144-2018·2018-03-28
Merit Medical Recalls Custom Dialysis Kits with Incorrect Catheter Configuration
Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.
Product
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1153-2018·2018-03-28
Bovie Medical Recalls J-Plasma Precise OPEN Devices Due to Seal Defect
Bovie Medical is recalling 1,005 J-Plasma Precise OPEN units worldwide because a cable plug defect may cause an incomplete helium seal, risking cross-contamination.
Product
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1101-2018·2018-03-28
Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage
Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they are breaking at the mid-shaft bond during use.
Product
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2018·2018-03-28
MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 55 Tesio Catheter Sets because potential connection failures could lead to blood loss or air emboli.
Product
12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2018·2018-03-28
Smiths Medical Recalls Medfusion Syringe Pumps Due to Syringe Recognition Issues
Smiths Medical is recalling Medfusion Syringe Pumps because they may fail to recognize or misidentify loaded medication syringes, potentially preventing proper pump programming.
Product
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2018·2018-03-28
Genicon EZEE Retrieval recalled due to plastic handle breaking off shaft
Genicon, Inc. is recalling 2,967 units of GENICON EZEE Retrieval because the plastic handle may break off the shaft, inhibiting proper removal.
Product
GENICON EZEE Retrieval, sterile, Rx only.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1091-2018·2018-03-28
Centurion Medical Recalls Latex Free IV Start Sets
Centurion Medical Products Corporation is recalling Latex Free IV Start Sets due to a Class II FDA recall. The products were distributed nationally.
Product
LATEX FREE IV START SET
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1098-2018·2018-03-28
Centurion Medical Recalls Wound Closure Tray - Facial Devices
Centurion Medical Products Corporation is recalling Wound Closure Tray - Facial devices due to a Class II FDA recall.
Product
WOUND CLOSURE TRAY - FACIAL
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1157-2018·2018-03-28
Bovie J-Plasma Precise FLEX Recall for Incomplete Cable Seal
Bovie Medical is recalling 12 units of the J-Plasma Precise FLEX due to a potential seal failure that could allow patient fluid backflow and cross-contamination.
Product
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1126-2018·2018-03-28
MedComp Catheter Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 315 Catheter Repair Kits due to potential connection failures that could cause blood loss or air emboli.
Product
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1148-2018·2018-03-28
Siemens Artis one Fluoroscopic X-Ray System Recalled for Table Defect
Siemens is recalling 16 Artis one fluoroscopic x-ray systems because a missing or incorrect snap ring could cause the tabletop to slide to the floor.
Product
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include…
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1095-2018·2018-03-28
Centurion Medical Recalls Neonatal IV Start Kits Due to Quality Concerns
Centurion Medical Products Corporation is recalling specific lots of Neonatal IV Start Kits. The recall is a Class II action, indicating a potential risk of temporary or medically reversible health consequences.
Product
NEONATAL IV START KIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1156-2018·2018-03-28
Bovie Medical Recalls J-Plasma Precise 360 Devices Due to Seal Defect
Bovie Medical is recalling J-Plasma Precise 360 devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.
Product
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1169-2018·2018-03-28
Beckman Coulter AutoMate Systems Recalled for Premature Belt Failure
Beckman Coulter is recalling AutoMate 1200, 1250, 2500, and 2550 systems due to premature belt failure that poses a remote risk of cross-contamination.
Product
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1092-2018·2018-03-28
Centurion Medical Recalls Pediatric IV and IV Start Kits
Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.
Product
PEDIATRIC IV & IV START KIT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1120-2018·2018-03-28
MedComp Recalls Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 712 Tesio catheter sets because connection failures could cause blood loss or air emboli.
Product
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1154-2018·2018-03-28
Bovie Medical Recalls J-Plasma Precise Devices Due to Cross-Contamination Risk
Bovie Medical is recalling J-Plasma Precise devices because a cable plug defect may allow patient fluid to backflow, creating a risk of cross-contamination.
Product
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Category
Medical Device
Distribution
0 states

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18501–18525 of 27682