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

7026–7050 of 27364

HighFDA (Devices)·Z-0072-2024·2023-10-11
Medical Device Recall: LFS Flat Screen Support Arm Bracket Failure
The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.
Product
LFS Flat screen support arm systems without 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 Support Arm Model Numbers
Category
Medical Device
Distribution
1 state
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-0010-2024·2023-10-11
Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape
Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.
Product
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0069-2024·2023-10-11
Zimmer Dermatome Blades recalled for producing thin, non-uniform skin grafts
Zimmer Surgical is recalling dermatome blades that produce thin, non-uniform skin grafts during surgical use. The defect may require additional surgical harvests to adequately cover grafting sites.
Product
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0011-2024·2023-10-11
Cardiac Guide Catheter Recalled Due to Incorrect Tip Curve Shape
Boston Scientific recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes that differ from labeled specifications. Approximately 8,475 units were distributed nationwide.
Product
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
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-0025-2024·2023-10-11
BD Cathena IV Catheter Safety Shield May Fail to Properly Engage
Becton Dickinson is recalling BD Cathena IV catheters because the safety shield may fail to properly engage, potentially exposing the contaminated needle.
Product
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
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-2651-2023·2023-10-11
Cuff Pressure Manager Power Inlet Dislodgment Prevents Charging
The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.
Product
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Category
Medical Device
Distribution
16 states
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-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-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-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-2658-2023·2023-10-11
HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect
The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.
Product
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0038-2024·2023-10-11
AB Sciex 4500MD Triple Quad Mass Spectrometer Recall Due to Fire Risk
AB Sciex has recalled 38 units of the 4500MD Triple Quad Mass Spectrometer nationwide due to a rare risk of flame and electrode ejection from solvent leaks combined with electrical discharge.
Product
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0016-2024·2023-10-11
Guider Softip XF Guide Catheter recalled for incorrect tip curve shape
Boston Scientific Corporation is recalling 326 units of Guider Softip XF Guide Catheters due to certain lots being distributed with an incorrect tip curve shape that differs from the labeled specifications.
Product
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
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-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
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-2639-2023·2023-10-04
3M Attest Sterilization Indicator Caps May Melt or Crack
3M is recalling 172,464 units of Attest biological indicators used to validate steam sterilization because caps may melt, deform, or crack during sterilization at 132°C and 135°C.
Product
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
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-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-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-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

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7026–7050 of 27364