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

9051–9075 of 40095

ModerateFDA (Devices)·Z-0084-2024·2023-10-18
Cardinal Health surgical procedure packs recalled for defective components
Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.
Product
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0002-2024·2023-10-11
Arrow ErgoPack central venous catheter recalled for incorrect labeling
ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.
Product
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0004-2024·2023-10-11
FDA Recalls Arrow PICC Catheters with Incorrect Product Code Labels
Arrow INTERNATIONAL recalled 172 units of ErgoPack PICC catheters due to incorrect product code and product name labels. The error affected lot 13F22G0508 distributed in the US.
Product
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0001-2024·2023-10-11
Arrow PICC Catheters Recalled for Incorrect Product Label Information
Arrow International recalled 1,173 PICC line units due to incorrect product code and name on packaging labels. Affected lot 33F23B0781 was distributed in the US.
Product
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0003-2024·2023-10-11
Arrow Central Venous Catheter Recalled for Incorrect Lidstock Labeling
Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.
Product
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2665-2023·2023-10-11
Qiagen therascreen KRAS PCR Kit Handbook Error Could Cause False Negative Results
Qiagen is recalling therascreen KRAS RGQ PCR Kits due to ambiguous handbook instructions that could lead to false negative results in cancer mutation detection. All kits with expiry dates of March 2023 or later are affected.
Product
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2660-2023·2023-10-11
Veran Endobronchial Navigation Devices Recalled for Manufacturing Non-conformance
Olympus is recalling Veran endobronchial navigation devices (6,484 units) worldwide due to manufacturing non-conformances and insufficient evidence of adequate electromagnetic compatibility. The devices may not function acceptably in environments with electromagnetic interference.
Product
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for u
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.
Product
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0071-2024·2023-10-11
LFS flat screen arm system surgical lamp bracket stopper block defect
The LFS flat screen arm system with surgical lamp has a broken or missing stopper block that could allow the screen to rotate excessively, potentially causing the spring shaft to break and shear off.
Product
LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Arm System Model Numbers LFSST2323, LFSLFSST29TV23, LFSST29TV23, LFSST23TV, LFSST23, LFS
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2652-2023·2023-10-11
Medical Ultrasound Cart Recall: Tilt Mechanism Failure Can Cause Equipment to Fall
GE Venue Go ultrasound carts can develop internal tilt mechanism failure, causing the system to detach from the cart and fall. Some 5,986 devices are affected worldwide.
Product
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2024·2023-10-11
Guider Softip Guide Catheters recalled for incorrect tip curve shape
Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.
Product
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0041-2024·2023-10-11
Real Intelligence CORI knee surgery software missing planning stage
Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.
Product
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2664-2023·2023-10-11
Veran Endobronchial Navigation System: Manufacturing and EMC Defects
Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.
Product
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.
Product
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.
Product
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0037-2024·2023-10-11
API3200MD Mass Spectrometer Recalled for Potential Fire Risk
AB Sciex is recalling three API3200MD mass spectrometers due to a rare risk of fire and electrode ejection from a solvent leak combined with electrical discharge. The flame could cause injury to users or property damage.
Product
API3200MD Mass Spectrometer, Part Number 4466230
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2649-2023·2023-10-11
Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly
Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.
Product
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0017-2024·2023-10-11
Cardiac guide catheter recalled for incorrect tip curve shape
Boston Scientific is recalling 1,728 units of Guider Softip Guide Catheter 6F due to a manufacturing defect producing incorrect tip curve shapes differing from labeled specifications.
Product
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0012-2024·2023-10-11
Cardiac guide catheters recalled for incorrect tip curve
Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.
Product
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2023·2023-10-11
Philips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues
Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.
Product
Incisive CT, software version 5.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2653-2023·2023-10-11
Apellis Injection Kit Filter Needles Recalled for Structural Defects
Apellis Pharmaceuticals is recalling 61,943 units of Injection Kit components due to structural variations in the 19-gauge filter needle. No causal relationship has been established between the defect and the rare adverse events observed.
Product
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0013-2024·2023-10-11
Guider Softip Guide Catheter with Incorrect Tip Curve Shape
Boston Scientific is recalling Guider Softip Guide Catheters due to an incorrect tip curve shape that differs from the labeled specification. The affected units may not perform as intended during cardiac procedures.
Product
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2654-2023·2023-10-11
EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations
A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.
Product
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2655-2023·2023-10-11
Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms
Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.
Product
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2663-2023·2023-10-11
Veran Navigation System Biopsy Needle Devices: Electromagnetic Compatibility Issue
Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.
Product
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm
Category
Medical Device
Distribution
Distributed nationwide

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9051–9075 of 40095