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

2976–3000 of 5038

SevereFDA (Devices)·Z-1070-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk
ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1072-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1053-2019·2019-04-03
Philips UroDiagnost MRF Recall Due to Missing Locking Plate
Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cyst
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1042-2019·2019-04-03
Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.
Product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1030-2019·2019-03-27
CTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk
CTL Medical is recalling 133 Hex Drivers because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
Product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1031-2019·2019-03-27
CTL Medical Hex Driver Recall Due to Anti-Toggle Ring Separation Risk
CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
Product
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0992-2019·2019-03-20
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.
Product
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-0988-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling six Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Part Number ARD268400140A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0989-2019·2019-03-13
Maquet Flat Screen Monitor Holder Recalled for Grounding Non-Compliance
Getinge US Sales LLC is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0987-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling six Maquet XS Flat Screen Monitor Holders because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0990-2019·2019-03-13
Maquet XS Flat Screen Monitor Holder Recalled for Grounding Defect
Getinge is recalling four Maquet XS Flat Screen Monitor Holders in Arizona and Texas because they may not meet grounding requirements, posing a risk of electric shock.
Product
Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-0805-2019·2019-03-06
ICU Medical Recalls ChemoLock Vial Spike Due to Potential Burr Particulate
ICU Medical is recalling one lot of ChemoLock Vial Spike devices due to a potential for containing burr particulate. The recall covers 2,050 units distributed in the US and internationally.
Product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the sy
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-0918-2019·2019-03-06
Philips Ingenia 3.0T MRI System Recalled for Falling Speaker Hazard
Philips is recalling Ingenia 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0923-2019·2019-03-06
Philips Ingenia Elition X MRI Systems Recalled for Falling Speaker Hazard
Philips is recalling Ingenia Elition X MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0907-2019·2019-03-06
Philips Achieva MRI System Recalled for Falling Ceiling Speaker Hazard
Philips is recalling Achieva 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0876-2019·2019-03-06
Philips Intera 1.0T MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Intera 1.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0878-2019·2019-03-06
Philips MRI System Recall Due to Ceiling Speaker Magnetic Hazard
Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0884-2019·2019-03-06
Philips Achieva XR MRI Systems Recalled for Ceiling Speaker Hazard
Philips is recalling 11,226 Achieva XR MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0927-2019·2019-03-06
Philips Achieva 3.0T MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0926-2019·2019-03-06
Philips MR RT MRI Systems Recalled for Falling Ceiling Speaker Hazard
Philips is recalling MR RT MRI systems because ceiling speakers may fall due to magnetic attraction.
Product
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0922-2019·2019-03-06
Philips Ingenia Elition S MRI System Recalled for Falling Speaker Hazard
Philips is recalling Ingenia Elition S MRI systems because ceiling speakers may fall due to magnetic attraction.
Product
Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0893-2019·2019-03-06
Philips Achieva 3.0T MRI System Recalled Due to Ceiling Speaker Hazard
Philips is recalling 11,226 Achieva 3.0T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2019·2019-03-06
Philips Intera IT MRI Systems Recalled for Falling Ceiling Speaker Risk
Philips is recalling 11,226 Intera IT MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0924-2019·2019-03-06
Philips MR-OR 1.5T MRI Systems Recalled for Falling Speaker Hazard
Philips is recalling 11,226 MR-OR 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0895-2019·2019-03-06
Philips Intera 1.5T MRI System Recalled for Ceiling Speaker Hazard
Philips is recalling Intera 1.5T MRI systems because ceiling speakers may fall and be pulled by the magnetic field.
Product
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
Distributed nationwide

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