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

9576–9600 of 39932

HighFDA (Devices)·Z-2172-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling probe cover kits used with diagnostic ultrasound procedures due to inadequate seam barriers that may compromise sterility. The recall affects 1,861 units distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2197-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate barrier at seams
Medline is recalling Probe Cover Kits (Model MNS10750A) used in diagnostic ultrasound procedures because the probe covers may have an inadequate barrier at the seams, potentially affecting protective effectiveness.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling 2739 units of probe cover kits used in diagnostic ultrasound and catheter insertion procedures due to inadequate barriers at seams that could compromise sterility.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline has recalled approximately 3.7 million ultrasound probe cover kits due to inadequate barriers at the seams that could affect sterile field integrity during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers
Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling ultrasound probe cover kits for an inadequate barrier at the seams that could compromise sterility. The recall affects 1,130 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2164-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling ultrasound probe cover kits containing sterile gel due to inadequate barriers at the seams, which may fail to maintain sterility during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2167-2023·2023-07-26
Medline Probe Cover Kits: Inadequate Seam Barrier Risk
Medline probe cover kits used in ultrasound-guided medical procedures may have inadequate barriers at the seams, posing a contamination risk. Approximately 270,000 units distributed worldwide since December 2017 are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling multiple probe cover kits used in diagnostic ultrasound and vascular access procedures due to inadequate barriers at the seams. No illnesses or injuries have been reported.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER P
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2214-2023·2023-07-26
Ultrasound reporting software recalled by manufacturer for software issue
Digisonics has voluntarily recalled OBView ultrasound reporting software versions 4.8.2 SP6 through 4.8.3 due to a software issue. The recall affects 32 units distributed across multiple U.S. states and Aruba.
Product
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2146-2023·2023-07-26
Aesculap Surgical Needle Recalled for Incorrect Product Code Marking
Aesculap Implant Systems is recalling Aesculap Surgical Needles (MD610) because they are etched with an incorrect product code. The needles are marked MD611 when they should be marked MD610.
Product
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2103-2023·2023-07-19
Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2104-2023·2023-07-19
Spectrum IQ Infusion System False Occlusion Alarm Correction Issued
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
Product
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2018-2023·2023-07-19
Oxylog 3000 Plus ventilator may stop working during operation
The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.
Product
Oxylog 3000 Plus emergency and transport ventilator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2110-2023·2023-07-19
Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
Product
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
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
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-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-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-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-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-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-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-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-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

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