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

12226–12250 of 13802

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
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
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-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-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-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-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-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-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-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-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
0 states
ModerateFDA (Devices)·Z-0643-2022·2022-02-23
Dental Resins Recalled for Manufacturing Facility and Origin Labeling Violations
Envisiontec US LLC recalled 795 units of FLEXCERA SMILE dental resins manufactured between April 2021 and September 2021 because they were produced in a non-FDA-registered facility and falsely labeled as German origin.
Product
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0650-2022·2022-02-23
Merete PediatrOS RigidTack surgical device recalled for incorrect size label
Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.
Product
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0647-2022·2022-02-23
Wireless Foot Switch May Stop Responding During Medical Procedures
Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.
Product
Zenition 50, Model #718096
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-0645-2022·2022-02-23
Howmedica Dall Miles SM GRIP surgical device recalled for potential package de-bonding
Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.
Product
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0641-2022·2022-02-23
Microbiology quality control kit recalled for incorrect inner label
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
Product
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Category
Medical Device
Distribution
Distributed nationwide
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-0595-2022·2022-02-16
GE Healthcare MR Magnets Cryogenic Ventilation System Defect Recall
GE Healthcare is recalling 17,228 MR superconducting magnet systems because the cryogenic ventilation system may not meet required venting standards.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2022·2022-02-16
Baxter MiniCap PD Transfer Sets Recalled Due to Damage from Cleaning Products
Baxter Healthcare is recalling 344,190 units of MiniCap Extended Life PD Transfer Sets worldwide because certain cleaning products may cause the sets to leak or crack, potentially affecting patient dialysis treatment.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0570-2022·2022-02-16
Baxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
Baxter MiniCap Extended Life PD Transfer Sets may be damaged by certain cleaning products containing hydrogen peroxide, bleach, alcohol, or solvents, potentially causing leaking or cracking. No injuries have been reported.
Product
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Category
Medical Device
Distribution
0 states
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-0562-2022·2022-02-16
Novalung Sensor Box Communication Failure May Disable Flow Measurement
The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.
Product
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0633-2022·2022-02-16
CURAD Reusable Gel Hot/Cold Pack Contains Undisclosed Natural Rubber Latex
Medline Industries is recalling 494,273 CURAD Reusable Gel Hot/Cold Packs because the product contains natural rubber latex that is not disclosed on the label. Consumers with latex allergies face risk of allergic reaction.
Product
CURAD REUSABLE GEL HOT/COLD PACK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0613-2022·2022-02-16
GE MRI superconducting magnet systems recalled for cryogen ventilation system defect
GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.
Product
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide

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