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

9101–9125 of 40056

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-2662-2023·2023-10-11
Veran Endobronchial Navigation Devices Recalled for Design Non-Conformance and EMC Issues
Olympus Corporation recalls Veran endobronchial navigation devices due to manufacturing non-conformances and insufficient electromagnetic compatibility. Approximately 6,318 units distributed worldwide are affected.
Product
Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0070-2024·2023-10-11
Medical Convenience Kit Recalled for Defective Dermatome Blades
ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.
Product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2659-2023·2023-10-11
Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance
Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.
Product
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-240
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-0024-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.
Product
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2024·2023-10-11
Bard Marquee Core Biopsy Kit recalled for needle-cannula diameter mismatch
Bard Peripheral Vascular is recalling 1,545 Bard Marquee biopsy kits because of a diameter mismatch between the biopsy needle and coaxial cannula. This defect may prevent proper tissue access during procedures and lead to complications including bleeding and pneumotharax.
Product
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
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-0021-2024·2023-10-11
Guide Catheter Recalled for Incorrect Tip Curve Shape
Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.
Product
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0015-2024·2023-10-11
Guider Softip XF Guide Catheter Recalled for Incorrect Tip Curve Shape
Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from labeled specifications, affecting 1,086 units in Indiana.
Product
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2648-2023·2023-10-11
Siemens MAGNETOM headphones may create artifacts during MRI imaging
Siemens Medical Solutions is recalling over-ear headphones used with MAGNETOM MRI systems. Lubricating grease in the headband may cause visible imaging artifacts during head examinations.
Product
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 1140
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2657-2023·2023-10-11
Medtronic Restore Clinician Programmer software recalled for compatibility issue
Medtronic is recalling Restore Clinician Programmer Application Software due to compatibility issues with legacy software that prevent communication with implanted neurostimulators. The recall affects 2,408 devices worldwide.
Product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2631-2023·2023-10-04
Philips Respironics V60 and V60 Plus Ventilators Power Management Failure Recall
Philips Respironics V60 and V60 Plus ventilators are recalled because their power management components may fail, causing complete loss of ventilator function. The FDA classified this as a Class I recall.
Product
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2638-2023·2023-10-04
3M Attest Biological Indicators Recalled for Defective Caps
3M is recalling specific lots of Attest biological indicators used in steam sterilization monitoring. Certain lots have caps that may melt, deform, or crack at sterilization temperatures of 132°C and 135°C, potentially compromising sterilization process verification.
Product
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2645-2023·2023-10-04
Stryker Recalls Expired Cinchlock SS Knotless Anchor Inserter Units
Stryker Corporation is recalling 96 units of the expired Cinchlock SS Knotless Anchor Inserter (Part Number CAT02462, Lot 19175AE2) distributed nationwide. Expired surgical devices may not perform reliably during use.
Product
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2637-2023·2023-10-04
3M Attest Biological Indicator caps may fail during steam sterilization
3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.
Product
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2636-2023·2023-10-04
ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall
J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.
Product
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2632-2023·2023-10-04
Palindrome Chronic Catheter Kit recalls devices with incorrect length labeling
Covidien LP is recalling Palindrome Chronic Catheter Kit devices where some catheters labeled as 23 cm implant length actually contain 28 cm devices. The mislabeling could affect proper catheter placement.
Product
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2643-2023·2023-10-04
B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage
B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.
Product
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2646-2023·2023-10-04
Medical Device Software May Display Duplicate Medication Doses
BD Pyxis MedBank MedPass Software may continue displaying dispensed medication doses as available, risking duplicate medication administration to patients.
Product
BD Pyxis MedBank MedPass Software, REF: 139088-01
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2628-2023·2023-10-04
Ambu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk
Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.
Product
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2644-2023·2023-10-04
B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall
B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.
Product
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2641-2023·2023-10-04
MobileLink Acetabular Cup System Recalled for Incorrect Offset Labeling
Waldemar Link is recalling 8 units of the MobileLink Acetabular Cup System due to labeling with an incorrect offset specification. The mislabeling could affect proper surgical placement of this orthopedic implant.
Product
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2633-2023·2023-10-04
exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning
Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.
Product
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2023·2023-10-04
3M Attest Biological Indicators Cap May Melt During Sterilization
3M is recalling 77,280 Attest biological indicators due to caps that may melt, deform, or crack during steam sterilization cycles, potentially compromising process validation.
Product
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Category
Medical Device
Distribution
Distributed nationwide

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9101–9125 of 40056