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

10301–10325 of 27470

SevereFDA (Devices)·Z-0628-2022·2022-02-23
Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use
Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.
Product
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0623-2022·2022-02-23
Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled
Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0627-2022·2022-02-23
Arrow-Trerotola Percutaneous Thrombolytic Device catheter tips may separate during use
The FDA is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters due to reports of tip separation during use. Approximately 3,668 units were distributed worldwide.
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0624-2022·2022-02-23
Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation
Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0646-2022·2022-02-23
Destino Twist and Guidestar Devices Recalled for Potential Threaded Component Separation
Oscor Inc. is recalling 549 units of Destino Twist and Guidestar devices due to potential separation between the threaded hub and cap. Affected devices were distributed in Tennessee, Pennsylvania, and the Czech Republic.
Product
Destino Twist 14F (also branded as Guidestar 14F)
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0652-2022·2022-02-23
Exeter V40 Cemented Hip Stem Labels May Mismatch Between Sizes
The FDA has recalled Exeter V40 Cemented Hip (150mm) Stems due to a potential labeling mix-up with the 125mm version. Patients who received the device should verify with their surgeon that the correct size was implanted.
Product
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0638-2022·2022-02-23
Endoscope Reprocessor Tubing Assembly Error May Reduce Disinfection Effectiveness
Olympus OER-Elite Endoscope Reprocessors may have incorrectly assembled detergent and alcohol tank tubing, causing solutions to be dispensed in reversed cycles. This results in ineffective endoscope disinfection and potential patient exposure to residual detergent.
Product
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2022·2022-02-23
Liko M220 mobile lifts recalled for missing bushing, fall risk
Hill-Rom is recalling 5,470 Liko M220 mobile lifts used in nursing homes due to a missing bushing that can cause wear and potentially lead to patient falls.
Product
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0640-2022·2022-02-23
Liko Mobile Patient Lifts Recalled for Missing Bushings and Wear Risk
Hill-Rom is recalling 1,215 Liko M220 and M230 mobile patient lifts with missing bushings that cause wear and risk of patient falls. Units were distributed worldwide.
Product
Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2022·2022-02-23
Smiths Medical Medfusion Syringe Infusion Pumps Recalled for Alarm System Failures
Smiths Medical is recalling certain Medfusion syringe infusion pumps due to intermittent alarm system failures that may occur during power-on self-tests outside the warranty period.
Product
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0648-2022·2022-02-23
Philips Zenition 70 Wireless Foot Switch Firmware Failure Recall
Philips is recalling Zenition 70 wireless foot switches due to a firmware issue that can cause the device to stop responding. This could interrupt imaging procedures if alternative controls are not used.
Product
Zenition 70, Model #718133
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0644-2022·2022-02-23
Howmedica Osteonics Medical Device Packaging Defect: Tyvek Lid De-bonding Recall
Howmedica Osteonics is recalling medical devices because the outer Tyvek lid may separate from the package seal. This affects 32MM -4 V40 TAPER VIT HEAD devices distributed worldwide.
Product
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0642-2022·2022-02-23
Dental Resin Product Recalled Due to Non-Registered Manufacturing and Mislabeling
Envisiontec US Llc recalls FLEXCERA BASE dental resin (574 units manufactured April–September 2021) due to manufacturing in a non-FDA-registered facility and mislabeling of country of origin.
Product
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0651-2022·2022-02-23
Exeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
Howmedica Osteonics is recalling Exeter V40 Cemented Hip (125mm) Stem devices due to a potential label mix with 150mm stems. Incorrect labeling could result in wrong implant size being used during surgery.
Product
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0649-2022·2022-02-23
Wireless Foot Switch Firmware Issue in Philips Veradius Unity Devices
The wireless foot switch in Philips Veradius Unity medical systems can lose function due to a firmware issue. This could cause delays or interruption of medical procedures if alternative input methods are not used.
Product
Veradius Unity, Model #718132
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0564-2022·2022-02-16
FDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
E25Bio COVID-19 diagnostic tests have been recalled following nationwide distribution without FDA authorization or approval. The distributed units lacked sufficient directions and quality controls needed for safe diagnostic use.
Product
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0586-2022·2022-02-16
Diagnostic Control Microorganism Recalled for Incorrect Test Results
Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.
Product
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2022·2022-02-16
LYFO DISK Streptococcus Pneumoniae Culture Kit Recalled for Bacterial Contamination
Microbiologics Inc is recalling LYFO DISK Streptococcus pneumoniae microorganism culture kits (lot 947-126-1) distributed worldwide due to potential contamination with E. coli, Staphylococcus epidermidis, and S. warneri.
Product
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorg
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0601-2022·2022-02-16
GE Healthcare MRI Cryogen Ventilation System Defect Recall
GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2022·2022-02-16
KWIK-STIK Quality Control Sets recalled for potential bacterial contamination
Microbiologics Inc is recalling KWIK-STIK QC Sets and Panels due to potential contamination with E. coli and Staphylococcus species. The affected product was distributed worldwide to laboratory testing facilities.
Product
QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that conta
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2022·2022-02-16
MIC Percutaneous Endoscopic Gastrostomy Kits Recalled for Oversized Retention Bolster
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.
Product
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0597-2022·2022-02-16
GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation
GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These systems were distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0604-2022·2022-02-16
GE Healthcare MR Superconducting Magnets Recalled for Ventilation Defect
GE Healthcare recalled 17,228 superconducting magnets, a component of SIGNA 1.5T MR systems, due to a cryogen ventilation system that may not meet venting requirements. Systems are distributed nationwide and internationally.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0618-2022·2022-02-16
GE Healthcare MRI Systems Cryogenic Ventilation System Failure Recall
GE Healthcare is recalling 17,228 MR Vectra MRI systems because the cryogenic ventilation system may not meet required venting specifications.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0630-2022·2022-02-16
BD Veritor Plus Analyzer may overheat when using unauthorized power adapter
BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.
Product
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

10301–10325 of 27470