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

8651–8675 of 13683

HighFDA (Devices)·Z-2267-2023·2023-08-09
Olympus SPiN Drive Triple Needle Brush Recalled for Sensor Malfunction
Olympus Corporation recalls the Always-On Tip Tracked Triple Needle Brush due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2282-2023·2023-08-09
Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk
Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.
Product
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2332-2023·2023-08-09
Medline Recalls Procedural Kits Over Sterility Specification Failure
Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2023·2023-08-09
Olympus SPiN Drive Forceps Recalled for EM Sensor Malfunction
Olympus SPiN Drive Forceps are being recalled due to an electromagnetic sensor malfunction that disables navigation functionality during endobronchial procedures, potentially causing procedural delays. No injuries reported.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Failure
Medline has recalled approximately 29,277 procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall covers kits distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2023·2023-08-09
X-ray therapy system carriage bolts may loosen and suspension rail crack
Philips Azurion 7 M20 X-ray imaging systems may have loose or broken carriage support bolts and cracks in the suspension rail. The Class II recall affects 648 units distributed worldwide.
Product
Azurion 7 M20. X-ray Image guided Therapy System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2023·2023-08-09
X-Ray Ceiling Tube Support System Recalled Due to Loose Fixing Bolts
Shimadzu ceiling tube supports used with X-ray systems may have loose or missing fixing bolts at the base. The company is providing service to install cables and brackets to prevent the device from falling.
Product
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2023·2023-08-09
NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.
Product
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2337-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2283-2023·2023-08-09
X-ray Imaging System Carriage Bolts May Loosen or Break
Philips Allura Xper FD10 and FD20 X-ray systems may have loose or broken bolts supporting the FlexMove Carriage and cracks in the suspension rail. Affected units distributed worldwide; users should inspect equipment and contact manufacturer.
Product
Allura Xper FD10 and FD20. X-ray Imaging System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2023·2023-08-09
Medline procedural kits with ultrasound gel may not meet sterility specifications
Medline Industries recalls 146,157 custom procedural kits distributed April 2020 to April 2023 because the sterile ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2023·2023-08-09
Image intensifier detachment hazard in OEC fluoroscopy imaging systems
GE OEC field upgrade kits for fluoroscopy systems may have image intensifiers that detach during movement, potentially falling and causing injuries.
Product
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2023·2023-08-09
Medline Procedural Kits Recalled for Potential Sterility Specification Failure
Medline has recalled 63,823 custom procedural kits due to potential sterility specification failure of the ultrasound gel component. The affected kits were distributed worldwide from April 2020 through April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2023·2023-08-09
VERITAS Advanced Infusion and Fluidics Packs Recalled for Weld Defect
Johnson & Johnson is recalling 148,941 VERITAS Advanced Infusion and Fluidics surgical packs due to weld defects that could cause vacuum failure during surgery, potentially leading to surgical delays and temporary eye swelling.
Product
VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2023·2023-08-09
ACROBAT-i Vacuum Stabilizer Blade Latching Failure in Cardiac Surgery Systems
A latching mechanism in the ACROBAT-i Vacuum Stabilizer System may fail during cardiac surgery, potentially causing loss of heart stabilization or device component release. The defect affects 334 units distributed worldwide.
Product
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2023·2023-08-09
NanoZoomer S360MD Slide Scanner May Record Incorrect Barcode Information
Hamamatsu's NanoZoomer S360MD slide scanner may record incorrect barcode information in the NDPi file, potentially causing pathologists to reference the wrong patient's digital slide image.
Product
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2259-2023·2023-08-09
Incisive CT Computed Tomography System: Metal Mounting Box May Detach
A metal mounting box in the Incisive CT scanner may become expelled, potentially injuring users or causing the system to shut down. Philips is recalling 20 affected units distributed internationally.
Product
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2273-2023·2023-08-09
ACROBAT V Cardiac Stabilization System may fail to secure during surgery
A latch defect in the ACROBAT V Vacuum Off-Pump System may prevent proper heart stabilization during cardiac surgery. Maquet Cardiovascular recalled 594 units distributed worldwide.
Product
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2310-2023·2023-08-09
Custom Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline recalls 4,618 custom sterile procedural kits distributed worldwide from April 2020 through April 2023. The Turkuaz ultrasound gel component may not meet sterility specifications, posing a potential infection risk in surgical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2023·2023-08-09
Medline procedural kits recalled for potential sterility failure in ultrasound gel
Medline Industries is recalling 148,445 procedural kits containing Turkuaz Ultrasound Gel over potential sterility failure of the gel component, which could lead to infections if used in sterile procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2023·2023-08-09
Procedural Kits with Ultrasound Gel May Not Meet Sterility Specifications
Medline Industries is recalling 144 custom procedural kits containing Turkuaz Ultrasound Gel because the sterile gel component may not meet required sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2023·2023-08-09
Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure
Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.
Product
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2265-2023·2023-08-09
Olympus SPiN Drive Histology Needle Recalled for Navigation Sensor Malfunction
Olympus recalls SPiN Drive histology needles due to electromagnetic sensor tracking malfunction that impairs navigation functionality during endobronchial procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2251-2023·2023-08-09
Surgical table drapes and infection control kits recalled for naphthalene odor
Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.
Product
Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-steril
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2249-2023·2023-08-09
Gore Tips Set Device Recall: Incorrect Expiration Date Labeling
Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.
Product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Category
Medical Device
Distribution
Distributed nationwide

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8651–8675 of 13683