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

11526–11550 of 13717

HighFDA (Devices)·Z-1296-2022·2022-07-06
SOLTIVE SuperPulsed Laser Fibers recalled for model and size labeling mismatch
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.
Product
SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1303-2022·2022-07-06
Fresenius Optiflux 200NRe Dialyzers Recalled Due to Temperature Exposure
Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.
Product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1288-2022·2022-07-06
FDA recalls MAC laryngoscope sets due to packaging error
Baxter Healthcare Corporation is recalling MAC laryngoscope devices due to a packaging error. The recall affects 99 units distributed worldwide.
Product
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1301-2022·2022-07-06
IVUS Catheter Recall: Missing Contraindications in Instructions
Volcano Corp is recalling Visions PV. 035 Digital IVUS Catheters because instructions for use do not include contraindications information. Healthcare providers should contact the manufacturer for complete safety documentation before use.
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1302-2022·2022-07-06
Digital IVUS Catheter Recalled for Missing Contraindication Information
Volcano Corp is recalling 7,520 units of the Volcano Visions PV. 035 Digital IVUS Catheter due to missing contraindication information in the instructions for use. The IFU lacks details about situations where the device should not be used.
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1278-2022·2022-06-29
Anesthesia System Suction Switch Crack Recall: Potential Equipment Failure
Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.
Product
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1266-2022·2022-06-29
HeartWare HVAD Battery Model 1650DE May Malfunction Due to Weld Defect
Medtronic is recalling HeartWare HVAD batteries (Model 1650DE) due to an internal weld defect that can cause battery malfunction and prevent proper charging. Approximately 429 affected batteries were distributed worldwide.
Product
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1279-2022·2022-06-29
Anesthesia system suction switch may crack and fail to activate
Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.
Product
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1272-2022·2022-06-29
Medfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
Smiths Medical is recalling multiple Medfusion Syringe Pump models due to software and hardware defects that may interrupt drug infusion or cause over-infusion. Approximately 65,093 units distributed worldwide are affected.
Product
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, S
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1271-2022·2022-06-29
Medfusion Syringe Pump Recalled Due to Multiple Infusion Control and Alarm Failures
Smiths Medical recalled 58,671 Medfusion Syringe Pump units worldwide due to multiple failures that could interrupt therapy or cause over-infusion, including defective alarms and display errors.
Product
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1281-2022·2022-06-29
BVI Wet-Field Eraser surgical devices shipped with incorrect tip configuration
Beaver Visitec International recalled 660 units of BVI Wet-Field Eraser surgical devices after discovering boxes labeled with one tip configuration contained a different tip design. This mismatch could affect surgical precision and hemostasis control.
Product
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1274-2022·2022-06-29
Colonovideoscope Model CF-H180AL recalled due to narrowed viewing angle
Olympus Corporation recalls a single colonovideoscope model CF-H180AL because an incorrect camera unit was installed, causing narrower viewing angle and potential device protrusion that could injure tissue. No injuries have been reported.
Product
Colonovideoscope Model CF-H180AL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2022·2022-06-29
FDA Recalls Catheter Drainage Kits With Wrong Needle Size
Bard Peripheral Vascular Inc is recalling certain catheter drainage kits that may contain an 8 Fr needle instead of the correct 6 Fr needle. The incorrect needle size could cause tissue injury during patient care.
Product
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2022·2022-06-29
FDA Recalls Metalogix Slotted 90 Tubular Wrench Due to Manufacturing Error
New Standard Device Inc is recalling 14 Metalogix Slotted 90 Tubular Wrenches (Lot A29618A) due to a manufacturing error that causes the wrench to strip nuts when torqueing. No injuries have been reported.
Product
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1282-2022·2022-06-29
INTERGARD Woven Vascular Graft mislabeled with incorrect size specification
Maquet Cardiovascular recalls INTERGARD Woven Vascular Grafts with incorrect labeling. Units labeled as 8 mm diameter instead contained 32 mm diameter grafts.
Product
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic gr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2022·2022-06-29
Alcon Clareon IOL mislabeled due to manufacturing error
Alcon is recalling specific lots of Clareon intraocular lenses (IOLs) due to mislabeling caused by improper manufacturing line clearance. The mislabeling resulted from partial product mixing during overlapping manufacturing runs.
Product
Alcon Clareon IOL with AutonoMe Delivery System
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1275-2022·2022-06-29
EVIS EXERA II Gastrointestinal Videoscope Recalled for Incorrect Component Fit
Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.
Product
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1283-2022·2022-06-29
Cardiac device software recalled for inadequate electrical insulation
CardioTek EP-TRACER Software V2.x is recalled because it failed electrical safety testing for insulation. The 146 affected units were distributed worldwide.
Product
CardioTek EP-TRACER Software V2.x.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1211-2022·2022-06-22
Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion
Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.
Product
Drager SafeStar 55, Catalog No. MP01790
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2022·2022-06-22
Tandem t:slim X2 Insulin Pump Battery Display May Cause Insulin Delivery Failure
Tandem t:slim X2 insulin pumps may display inaccurate battery levels, risking insulin delivery failure if the battery depletes unexpectedly. Users should maintain battery above 25% to prevent unintended insulin cessation.
Product
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1262-2022·2022-06-22
Olympus endoscope diopter ring adhesive failure may impair vision
Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.
Product
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1264-2022·2022-06-22
Olympus Fiberscope Recalled for Defective Diopter Ring Adhesive
Olympus URETERO-RENO FIBERSCOPE Model URF-P6R recalled due to incorrect adhesive securing the diopter ring, which may cause loss of focus and in rare cases urinary tract perforation.
Product
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1267-2022·2022-06-22
Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
Product
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2022·2022-06-22
Philips OmniWire guide wire recalled for potential sterilization failure
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1265-2022·2022-06-22
GE CARESCAPE Central Station power supply failure recall
GE Healthcare is recalling CARESCAPE Central Station V2 patient monitoring devices due to potential power supply failure that can cause device shutdown and loss of patient monitoring.
Product
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSE
Category
Medical Device
Distribution
Distributed nationwide

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11526–11550 of 13717