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

7551–7575 of 27441

HighFDA (Devices)·Z-2200-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barrier
Medline Industries is recalling 70,648 ultrasound probe cover kits used in diagnostic and interventional procedures due to inadequate barriers at the seams.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2196-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barriers
Medline is recalling probe cover kits used in ultrasound procedures due to potential inadequate barriers at the seams that could affect product protection.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO BLOCK PACK-LF, Model Number PHS762887001B; d) TVS4700 CUSTOM PACK, Model Nu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2023·2023-07-26
Medline probe covers with inadequate seam barrier may allow contamination
Medline is recalling Probe Cover Kits due to inadequate barriers at the seams, which may allow contamination during ultrasound procedures. The recall affects 51,200 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling probe cover kits containing sterile ultrasound gel due to inadequate barriers at the seams, which may compromise sterility during diagnostic ultrasound procedures. The recall affects 2,590 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION
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-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-2181-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2153-2023·2023-07-26
Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage
DiaSorin Molecular is recalling the Simplexa Direct Amplification Disc Kit due to potential malfunction that could cause liquid to spill from the device.
Product
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2023·2023-07-26
RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
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-2208-2023·2023-07-26
GEM FLOW COUPLER Monitor LCD Display Fails to Show Correct Active Channel
Baxter Healthcare is recalling the GEM FLOW COUPLER Monitor due to an LCD display error that may fail to indicate the correct active channel when powered on using battery power. This could lead to incorrect channel selection during use.
Product
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2173-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barriers
Medline Industries is recalling 4,148 units of Probe Cover Kits used in diagnostic ultrasound procedures due to inadequate barriers at the seams.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Barrier Seals
Medline is recalling 10,080 ultrasound probe cover kits because the seams may not seal properly, potentially compromising barrier protection. The kits were distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC149
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2158-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PAC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Seam Defects
Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2190-2023·2023-07-26
Medline ultrasound probe cover kits recalled for inadequate seam barriers
Medline probe cover kits used in diagnostic ultrasound procedures may have inadequate barriers at the seams. The recall affects 540 units distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2160-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling 173,449 sterile probe cover kits due to inadequate seam barriers that may compromise sterility. The affected units were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2199-2023·2023-07-26
Medline probe cover kits recalled for inadequate seam barrier protection
Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Seam Barrier Defects
Medline is recalling ultrasound probe cover kits with sterile gel due to inadequate seam barriers that may compromise sterility during diagnostic procedures. Approximately 8,974 units distributed worldwide from 2017 to 2023 are affected.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2023·2023-07-26
MRI Biomet Pin Guide for Knee Surgery Shipped to Wrong Patient
Materialise N.V. is recalling MRI Biomet Pin Guides for total knee arthroplasty because the wrong patient-specific device was included in a shipment. Using an incompatible guide could affect surgical planning and implant placement.
Product
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2174-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling 770,147 ultrasound probe cover kits worldwide due to inadequate barriers at the seams. The defect could allow contamination during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Nu
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-2178-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
Category
Medical Device
Distribution
Distributed nationwide

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7551–7575 of 27441