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

9601–9625 of 13717

HighFDA (Devices)·Z-1353-2023·2023-04-19
PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction
Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2023·2023-04-19
Digital VIPR Oxygen Delivery Systems Recalled for Gauge Malfunction
Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.
Product
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1370-2023·2023-04-19
Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure
Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.
Product
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2023·2023-04-19
Inflatable Penile Prosthesis Pump Risk of Premature Failure
Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.
Product
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2023·2023-04-19
Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk
Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.
Product
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1351-2023·2023-04-19
Outset Tablo Hemodialysis System Recall Due to Software Manufacturing Defect
Outset Medical is recalling 374 Tablo hemodialysis systems due to a software malfunction introduced during manufacturing. The defect causes frequent high conductivity dialysate alarms in devices distributed nationwide.
Product
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1359-2023·2023-04-19
Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk
Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device failure.
Product
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2023·2023-04-19
Knee Patella Drills Recalled for Incorrect Diameter Markings
Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.
Product
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1390-2023·2023-04-19
Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect
Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.
Product
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2023·2023-04-19
Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking
Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1378-2023·2023-04-19
BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.
Product
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2023·2023-04-19
Inflatable penile prosthesis recalled due to pump wall thickness manufacturing defect
Coloplast is recalling Titan NB inflatable penile prostheses with reduced pump wall thickness that may cause premature pump failure during normal use.
Product
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2023·2023-04-19
Chromic Gut Absorbable Sutures recalled due to sterilization failure
Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.
Product
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1375-2023·2023-04-19
Titan inflatable penile prosthesis recalled due to premature pump failure risk
Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.
Product
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2023·2023-04-19
Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients
Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.
Product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2023·2023-04-19
Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk
Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.
Product
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2023·2023-04-19
X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge
Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.
Product
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2023·2023-04-19
First Response Easy Read App unable to reliably read pregnancy test results
Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.
Product
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2023·2023-04-19
X-ray imaging system ceiling suspension may descend without adequate maintenance
Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.
Product
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2023·2023-04-19
Knee implant trial components recalled for incorrect size laser markings
Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1380-2023·2023-04-19
Thermodilution Catheter May Bend During Use, Causing Monitor Errors
Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.
Product
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1382-2023·2023-04-19
Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk
The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.
Product
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2023·2023-04-19
Titan Inflatable Penile Prosthesis Pump Failure Risk Recall
Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.
Product
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1371-2023·2023-04-19
Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk
Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure. No injuries have been reported.
Product
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2023·2023-04-19
Inflatable Penile Prosthesis Risk of Premature Pump Failure
Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.
Product
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide

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9601–9625 of 13717