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 the agency’s own highest classification or reported deaths or serious injuries, 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

17826–17850 of 40124

ModerateFDA (Devices)·Z-1570-2020·2020-04-01
Bard PowerPort Implantable Ports Recalled Due to Incorrect Catheter Barb Tip
Bard Peripheral Vascular Inc is recalling 178 PowerPort implantable ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgery.
Product
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1535-2020·2020-04-01
Beckman Coulter Recalls iChemVELOCITY Strips Due to Pad Switching Error
Beckman Coulter is recalling iChemVELOCITY Strips because the Leukocyte and Compensation pads were switched on some vials of lot 7212269M.
Product
iChemVELOCITY Strips, Catalog 800-7212
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1565-2020·2020-04-01
Cook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates
Cook Inc. is recalling 25 Pericardiocentesis Sets because the printed expiration dates are incorrect. The products were distributed to seven US states and Canada.
Product
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Category
Medical Device
Distribution
7 states
CriticalFDA (Devices)·Z-1499-2020·2020-03-25
Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.
Product
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1474-2020·2020-03-25
CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy
CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.
Product
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-1506-2020·2020-03-25
TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage
TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.
Product
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1508-2020·2020-03-25
Stryker Strykeprobe Outer Sheath Recalled for Potential Electrical Hazard
Stryker is recalling 525 Strykeprobe Outer Sheath Replacement devices due to a potential length mismatch that could cause sheath melting and unintended electrical flow to patients.
Product
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1521-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical, Inc. is recalling 628 custom procedure trays because they contain surgical gowns that may not be sterile. This poses a risk of surgical site infection and cross-contamination.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1502-2020·2020-03-25
Agfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error
Agfa N.V. is recalling two DR 800 X-ray systems because the tomosynthesis image acquisition sequence did not stop automatically after the expected number of exposures.
Product
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical, Inc. is recalling 1,906 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1524-2020·2020-03-25
Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities
Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.
Product
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1498-2020·2020-03-25
LivaNova Heater-Cooler System 3T Recalled for NTM Contamination Risk
LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.
Product
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1522-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Containing Non-Sterile Gowns
Avid Medical is recalling 2,632 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1497-2020·2020-03-25
Siemens Artis Angiography Systems Recalled for Software Movement Blockage
Siemens is recalling Artis angiography systems because a software issue could block stand and table movements.
Product
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1517-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical, Inc. is recalling 1,644 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1480-2020·2020-03-25
Aesculap Recalls Columbus Knee Implant Components Due to LDPE Particles
Aesculap Implant Systems LLC is recalling Columbus knee implant components because low-density polyethylene particles may be present on the surface when the packaging is opened.
Product
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K NN475K NN476K NN477K NN478K NN479K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1519-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 230 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1514-2020·2020-03-25
Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.
Product
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1512-2020·2020-03-25
Boston Scientific DYNAGEN EL ICD DR Recall for Unapproved Software
Boston Scientific is recalling one DYNAGEN EL ICD DR device because a software update downloaded unapproved applications to four programmers.
Product
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2020·2020-03-25
Siemens Artis Q Angiography Systems Recalled for Software Movement Issue
Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.
Product
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 5,004 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1501-2020·2020-03-25
Siemens Ysio X-Ray System Recalled for Unexpected Tube Stand Movement
Siemens is recalling Ysio X-Ray systems because a software error may cause the ceiling tube stand to move unexpectedly when activated by the user.
Product
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1503-2020·2020-03-25
TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.
Product
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1515-2020·2020-03-25
Avid Medical Recalls Custom Procedure Trays Due to Sterility Concerns
Avid Medical is recalling 21,326 custom procedure trays because they contain surgical gowns that may not be sterile, posing a risk of surgical site infection.
Product
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1481-2020·2020-03-25
Aesculap Recalls Knee Implant Components Due to Potential LDPE Particles
Aesculap Implant Systems LLC is recalling specific knee implant components because low-density polyethylene particles may be present on the surface upon opening.
Product
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z NN473Z NN474Z NN475Z NN476Z NN477Z NN478Z NN479Z Product Usage…
Category
Medical Device
Distribution
Distributed nationwide

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17826–17850 of 40124