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

28251–28275 of 40233

HighFDA (Devices)·Z-0482-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 70 units of Transpac IV transducer kits due to a potential leak. The devices are used for blood sampling and pressure monitoring.
Product
MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 660 Transpac pressure transducers and SafeSet reservoir kits due to a potential leak hazard.
Product
ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2017·2016-11-23
Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect
Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.
Product
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0429-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0425-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 520 Transpac IV transducer kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0493-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 20 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.
Product
MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0430-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 800 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0436-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Potential
ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial Pressure Tubing, Item No. 42594-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 125 Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.
Product
RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0448-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 200 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.
Product
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42643-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2017·2016-11-23
ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 260 units of Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.
Product
TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 100 units of Transpac IV transducer kits due to a potential leak. The affected items were distributed nationwide.
Product
DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 130 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential leak.
Product
TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 10 units of Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.
Product
Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2017·2016-11-23
ICU Medical Recalls Transpac IV Bifurcated Kits Due to Leak Risk
ICU Medical is recalling 340 units of Transpac IV Bifurcated Kits with SafeSet Reservoirs due to a potential for leaks.
Product
TRANSPAC¿ IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 820 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leaks.
Product
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2017·2016-11-23
ICU Medical Recalls Cath Lab Kits Due to Potential Leak
ICU Medical is recalling 272 cath lab kits containing SafeSet Reservoirs and Transpac IV transducers due to a potential for leak.
Product
CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Product
QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 1,480 Transpac IV transducers with SafeSet Reservoirs due to a potential leak. The products were distributed nationwide.
Product
TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 25 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
Product
Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 120 units of TP4 Monitoring Kits with SafeSet Reservoirs due to a potential leak. The devices are distributed nationwide.
Product
TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0460-2017·2016-11-23
ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 100 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.
Product
CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0445-2017·2016-11-23
ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 280 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential for leak.
Product
TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42640-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0462-2017·2016-11-23
ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 60 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.
Product
KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents…
Category
Medical Device
Distribution
Distributed nationwide

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28251–28275 of 40233