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

7451–7475 of 27393

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-2177-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barriers
Medline is recalling 4,398 probe cover kits used in ultrasound procedures due to inadequate seam barriers that may compromise sterility. 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) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FAC
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-2155-2023·2023-07-26
Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2023·2023-07-26
Aeris Balloon Dilation Catheter Mislabeled — FDA Class II Recall
Bryan Medical Inc is recalling the Aeris Balloon Dilation Catheter distributed nationwide in Georgia, New York, and Pennsylvania due to mislabeling of the devices.
Product
Aeris Balloon Dilation Catheter
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-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-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-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-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-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-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-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-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-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-2176-2023·2023-07-26
Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Num
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-2204-2023·2023-07-26
Medline Probe Cover Kits Recalled Due to Inadequate Seam Barriers
Medline is recalling Probe Cover Kits because probe covers may have inadequate seam barriers that could allow contamination during ultrasound procedures. Approximately 24,192 units were distributed worldwide from December 2017 to May 2023.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
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-2195-2023·2023-07-26
Medline Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility 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: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2186-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
Medline is recalling 14,848 ultrasound probe cover kits due to potentially inadequate barriers at the seams. The kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Numbe
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-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
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

How to read this listing

Filters

7451–7475 of 27393