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

15951–15975 of 27769

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 (Food)·F-0001-2024·2023-10-11
Vive Organic Wellness Shot Recalled for Undeclared Coconut Allergen
Vive Organic is recalling its Detox + Immunity wellness shots for undeclared coconut allergen. The product was distributed to retailers across 16 U.S. states.
Product
2 oz VIVE ORGANIC DETOX + IMMUNITY KIWI APPLE SUPERGREENS WELLNESS SHOT; Total package size: 12 bottles per case; Storage instructions: Keep Refrigerated; Date(s) of manufacture: 06/29/23 - 06/30/23
Category
Food
Distribution
16 states
HighFDA (Devices)·Z-0008-2024·2023-10-11
VITROS Proboscis/Piston Assembly Recall for Assay Accuracy Defect
Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.
Product
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0011-2024·2023-10-11
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.
Product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0009-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.
Product
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2024·2023-10-11
Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
Product
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0020-2024·2023-10-11
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.
Product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2656-2023·2023-10-11
GE F2-01 Frame Patient Monitor Communication Interruption Risk
GE F2-01 Frame physiological patient monitors may experience data communication interruptions with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors if not powered down within 120 days.
Product
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0021-2024·2023-10-11
FDA Recalls Fentanyl Injectable Syringes Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·23V761000·2023-10-11
Prevost Motor Coaches Recalled for Fire Risk in Grid Heater System
Prevost Car (US) Inc. is recalling 204 certain 2023-2024 H3-45 and X3-45 VIP motor coaches due to loose grid heater cable connections that can cause the relay to overheat, increasing fire risk.
Product
PREVOST — 2023 PREVOST H3-45 VIP
Category
Vehicle
Distribution
Distributed nationwide
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-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 (Drugs)·D-0007-2024·2023-10-11
Phenylephrine Injectable Syringes Recalled for Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
Product
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2650-2023·2023-10-11
IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety
Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.
Product
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
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-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-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-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-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 (Drugs)·D-0041-2024·2023-10-11
Drug Recall: Triamcinolone Acetonide Injectable Contains Glass Contamination
Eugia US LLC is recalling 1,626 vials of Triamcinolone Acetonide Injectable Suspension due to glass contamination. The affected lot (3TC22010, exp. 11/30/2024) was distributed nationwide.
Product
TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
Category
Drug
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 (Drugs)·D-0028-2024·2023-10-11
HYDROmorphone Injectable Syringes Recalled Over Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 1,190 units of HYDROmorphone injectable syringes nationwide due to lack of sterility assurance. Patients using affected lots should contact their healthcare provider.
Product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
Category
Drug
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-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-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

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