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

9526–9550 of 13717

ModerateFDA (Devices)·Z-1556-2023·2023-05-10
VITROS 5600 system pack opener assembly may not function properly
The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.
Product
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1555-2023·2023-05-10
VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps
The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.
Product
VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1558-2023·2023-05-10
DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update
DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.
Product
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1529-2023·2023-05-10
Knee implant system amended surgical technique and training guidance
Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.
Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1537-2023·2023-05-10
LINK SLED Knee System Tibial Implant Aseptic Loosening Risk
The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.
Product
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1545-2023·2023-05-10
LINK SLED Knee Implant Surgical Technique Update Required
The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.
Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1482-2023·2023-05-10
Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk
Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.
Product
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1506-2023·2023-05-10
DERMLITE DL4W Medical Device Recalled for Serial Number Labeling Discrepancy
DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.
Product
DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1557-2023·2023-05-10
VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
Product
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1464-2023·2023-05-03
VersaOne Positioning Cannula Recalled for Metal Burr Manufacturing Defect
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
Product
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1469-2023·2023-05-03
Angiography system display malfunction affects diagnostic imaging capability
Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.
Product
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10848600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2023·2023-05-03
Draeger Infinity CentralStation ECG waveform display inaccuracy due to software defect
Draeger Infinity CentralStation patient monitors may display ECG waveform amplitudes lower than actual values due to a software bug affecting versions VG2.1.3 and lower.
Product
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2023·2023-05-03
Surgical Convenience Kits Recalled Due to Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2023·2023-05-03
Sterile Surgical Kit Light Handle Covers May Separate During Use
ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.
Product
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2023·2023-05-03
Surgical forceps may fail to open when endoscope shaft is bent
Richard Wolf surgical forceps may fail to open when used during endoscopic procedures if the endoscope shaft becomes bent. Approximately 838 units are affected worldwide.
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1468-2023·2023-05-03
Mani Trocar Kits Recalled for Packaging Defect Compromising Sterility
Mani Trocar Kits (Models MTK23S and MTK25S) are being recalled due to a packaging defect that may compromise the sterile barrier. The recall affects 45 kits distributed to one consignee in Missouri.
Product
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1423-2023·2023-05-03
Biopsy forceps may fail to open when endoscope is bent
Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.
Product
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1466-2023·2023-05-03
Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
Wright Medical Technology recalls Stryker ORTHOLOC 3Di Fusion Plate MTP Right devices due to incorrect dorsiflexion descriptions laser marked on the parts. 41 units distributed nationwide.
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1421-2023·2023-05-03
Carefusion Vaginal Specula Recalled for Incorrect Labeling and Packaging
Carefusion recalled 726 units of two vaginal specula models with labels and laser etchings switched during packaging. This mislabeling could result in use of an unintended product.
Product
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1436-2023·2023-05-03
Sterile surgical C-section kit light handle covers recalled for separation risk
ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.
Product
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1465-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled Due to Internal Metal Burrs
Covidien LP is recalling VersaOne Reusable Positioning Cannulas (Model RC12STS) due to manufacturing defects that may produce metal burrs on the inside of the device, potentially causing internal tissue damage during use.
Product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2023·2023-05-03
Draeger Infinity M300 Patient Monitor Software Displays Inaccurate ECG Readings
Draeger Infinity M300/M300+ patient monitoring systems may display or print ECG waveforms with inaccurate QRS amplitudes due to software peaks being dropped on narrow waveforms.
Product
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1432-2023·2023-05-03
Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
Product
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2023·2023-05-03
VersaOne Reusable Positioning Cannula Recalled for Internal Metal Burr
Covidien LP is recalling 145 units of the VersaOne Reusable Positioning Cannula due to a manufacturing defect that may create a metal burr inside the device at the weld joint.
Product
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1470-2023·2023-05-03
Digital X-ray System Arm May Break, Posing Injury Risk
FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.
Product
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Category
Medical Device
Distribution
Distributed nationwide

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9526–9550 of 13717