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

8726–8750 of 13731

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-2271-2023·2023-08-09
Chest Stabilization Device Latch May Fail During Cardiac Surgery
The ACCESSRAIL Platform Standard Blade may fail to latch securely, potentially causing loss of heart stabilization or device component release into patients during cardiac surgery.
Product
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
Category
Medical Device
Distribution
Distributed nationwide
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-2320-2023·2023-08-09
Medical procedural kits recalled for potential sterile ultrasound gel defect
Medline is recalling 93,587 custom procedural kits worldwide 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. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A;
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-2308-2023·2023-08-09
Procedural Kits with Ultrasound Gel May Not Meet Sterility Standards
Medline is recalling 1,130 custom sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2336-2023·2023-08-09
Medline Procedural Kits Recalled Due to Sterility Specification Concerns
Medline Industries is recalling 211 custom procedural kits (egg retrieval, fetal surgery, TVT packs) worldwide because the sterile ultrasound gel component may not meet sterility specifications. 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. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2023·2023-08-09
Endobronchial Cytology Needles Recalled for Electromagnetic Sensor Malfunction
Olympus is recalling endobronchial navigation needles because an electromagnetic sensor malfunction can disable navigation guidance during medical procedures, potentially causing procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology 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
HighFDA (Devices)·Z-2261-2023·2023-08-09
CT Scanner Metal Mounting Box May Become Expelled, Posing Injury Risk
Philips is recalling Incisive CT Plus imaging systems due to a metal mounting box that may separate from the rotating scanner and potentially injure users.
Product
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
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-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-2286-2023·2023-08-09
Scican STATCLAVE G4 Chamber Autoclave Recall for Sterilization Risk
Scican has recalled 3 STATCLAVE G4 tabletop autoclaves due to risk of incomplete sterilization if used with incompatible loads. Healthcare facilities should verify only compatible materials are sterilized.
Product
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2023·2023-08-09
SPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays
Olympus SPiN Drive needles have an electromagnetic sensor tracking malfunction that impairs navigation during endobronchial clinical procedures. Affected devices may generate false coil break warnings and cause procedural delays.
Product
Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex 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 Mode
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-2338-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility concerns
Medline is recalling 15,323 custom sterile and non-sterile procedural kits worldwide due to potential non-sterility of the Turkuaz ultrasound gel component. 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. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: PAIN1524B; c. ARTHROGRAM TRAY, Model Number: PAIN1524A; d. CARPAL TUNNEL K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2023·2023-08-09
OEC 9900 Systems Image Intensifier Detachment and Fall Risk
GE OEC 9900 fluoroscopy systems' image intensifiers can detach during movement if subjected to large impact force, potentially falling and causing injuries such as fractures or bruising.
Product
OEC 9900 Systems with 9-inch Image Intensifier
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2023·2023-08-09
Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution
Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.
Product
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
Category
Medical Device
Distribution
7 states
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
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-2250-2023·2023-08-09
Ecolab Medical Device Drapes Recalled for Naphthalene Odor
Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.
Product
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab M
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2218-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
Product
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2217-2023·2023-08-02
Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
Product
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2221-2023·2023-08-02
Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Product
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2219-2023·2023-08-02
Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk
Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.
Product
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2223-2023·2023-08-02
LINEAR intra-aortic balloon catheter introducer dilator fracture risk
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Product
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
Category
Medical Device
Distribution
Distributed nationwide

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8726–8750 of 13731