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

8801–8825 of 13652

HighFDA (Devices)·Z-2137-2023·2023-07-19
Medline Non-Sterile PVP Surgical Solution Kits Mislabeled as Sterile
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2023·2023-07-19
Ambulance stretcher base leg assembly may bend causing tip and unstable motion
Stryker Power-PRO 2 ambulance cots may develop bent base leg assemblies, risking cot tips, unstable motion, and operational difficulties. Approximately 1,980 units were recalled.
Product
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2023·2023-07-19
Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2143-2023·2023-07-19
HeartSine Defibrillator Battery and Electrode Cartridges May Fail to Function
HeartSine battery and electrode cartridges for defibrillators may contain depleted battery cells, rendering them inoperable and preventing cardiac rhythm analysis or therapy delivery. Approximately 30,022 units are affected worldwide.
Product
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2023·2023-07-19
Medtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
Medtronic is recalling eight units of Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification device dimensions that could affect surgical fitting and spinal stability.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2124-2023·2023-07-19
Ultrasound Device Boot Failure May Delay Emergency Availability
Certain GE HealthCare Vivid S60 ultrasound systems may not boot up in a timely fashion, potentially delaying device availability in time-critical emergency situations.
Product
GE Healthcare Vivid S60, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2122-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2023·2023-07-19
Medtronic spinal implant recall due to out-of-specification device dimensions
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2023·2023-07-19
Medline Non-Sterile PVP Solution Kits Mislabeled as Sterile
Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2023·2023-07-19
Osteomed AutoDrive Screws Recalled for Undersized Screw Head
Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.
Product
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2023·2023-07-19
GE Vivid S70N Ultrasound Device Boot Failure Recall
GE Healthcare recalls certain Vivid S70N ultrasound devices that may not boot promptly, potentially delaying availability in time-critical emergencies.
Product
GE Healthcare Vivid S70N, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2129-2023·2023-07-19
Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.
Product
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile in Ophthalmic Kits
Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2023·2023-07-19
Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2023·2023-07-19
GE Healthcare Vivid S70 ultrasound systems fail to boot timely
GE Healthcare Vivid S70 ultrasound devices may experience delayed startup. This can reduce equipment availability during time-critical emergency situations.
Product
GE Healthcare Vivid S70, ultrasound device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2134-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2023·2023-07-19
Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2023·2023-07-19
Surgical chest support device recalled for potential cracking at attachment
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Product
Allen Advance Chest Support with Pad
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2023·2023-07-19
Medline PVP solution mislabeled as sterile when non-sterile
Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.
Product
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2107-2023·2023-07-19
Orthopedic Screw Recall Due to Undersized Head in Surgical Device
Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.
Product
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2023·2023-07-19
Medtronic Catalyft LS Spinal Implant Recalled for Out-of-Specification Geometry
Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine fusion surgery.
Product
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2132-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile Product
Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2028-2023·2023-07-12
FDA Recalls GE Healthcare Oximeter Sensors for Defibrillation and Electrical Hazards
GE Healthcare is recalling 2,097 TruSignal Sensitive Skin Sensor oximeters worldwide due to risks of reduced defibrillation energy, unintended electrical contact, and inaccurate measurements.
Product
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Category
Medical Device
Distribution
0 states

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8801–8825 of 13652