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

8851–8875 of 13731

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-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-2185-2023·2023-07-26
Medline ultrasound probe covers recalled for inadequate seam barrier
Medline Probe Cover Kits used in diagnostic ultrasound procedures are recalled because probe covers may have an inadequate barrier at the seams, potentially allowing contamination.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2023·2023-07-26
Medline Probe Cover Kits Recalled Due to Inadequate Seam Barrier
Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE BUNDLE KIT, Model Number DT13351A
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
HighFDA (Devices)·Z-2192-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Sterile Barrier
Medline Probe Cover Kits used during ultrasound procedures may have an inadequate barrier at the seams that could compromise sterility. The manufacturer is recalling 180 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2189-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling Probe Cover Kits with sterile Ultrasound Gel because the probe covers may have an inadequate barrier at the seams. These diagnostic ultrasound kits are distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2205-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline Industries is recalling 4,500 Probe Cover Kits because the covers have inadequate barriers at the seams, which may compromise sterility.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: 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 TO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect
Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline Industries is recalling ultrasound probe cover kits with inadequate barriers at the seams that could allow contamination during procedures. Approximately 3.7 million units distributed worldwide between December 2017 and May 2023 are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND
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-2206-2023·2023-07-26
Medline O.R. Scissors Recalled Due to Sterile Packaging Compromise Risk
Medline is recalling approximately 189,221 surgical scissors because they were manufactured without a tip protector, allowing them to break through sterile packaging and compromise product sterility.
Product
Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2159-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling probe cover kits used during diagnostic ultrasound procedures due to an inadequate barrier at the seams that may compromise sterile integrity.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0
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-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
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-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-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
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-2126-2023·2023-07-19
GE Healthcare Vivid S60N ultrasound devices experience boot-up delays
GE Healthcare Vivid S60N ultrasound systems may fail to boot in a timely manner. This can delay device availability during time-critical emergency situations.
Product
GE Healthcare Vivid S60N, ultrasound device
Category
Medical Device
Distribution
0 states
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-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-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

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8851–8875 of 13731