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 the agency’s own highest classification or reported deaths or serious injuries, 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

24351–24375 of 40175

ModerateFDA (Devices)·Z-1261-2018·2018-04-04
Siemens Syngo.via software recall due to data archiving configuration error
Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.
Product
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1224-2018·2018-04-04
Zimmer Biomet Recalls Persona Knee System Components Due to Missing Parts
Zimmer Biomet is recalling 3 units of the Persona Knee System because the set screw and taper plug were missing from the packaging.
Product
PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1210-2018·2018-04-04
Johnson & Johnson Recalls ACUVUE ADVANCE Contact Lenses Due to Foreign Matter
Johnson & Johnson Vision Care is recalling specific lots of ACUVUE ADVANCE contact lenses because foreign matter was found between the blister package and foil.
Product
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1272-2018·2018-04-04
SIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers
SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.
Product
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1206-2018·2018-04-04
Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error
Johnson & Johnson is voluntarily recalling select first aid wraps because the packaging incorrectly states they are not made with natural rubber latex.
Product
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1191-2018·2018-04-04
Zimmer Biomet Recalls Mismatched Hip Implant Packages
Zimmer Biomet is recalling 12 hip implant packages labeled as size 7.5 that actually contained size 4 implants.
Product
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1270-2018·2018-04-04
Roche cobas e 411 Analyzer Recall for Questionable Results
Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.
Product
cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1189-2018·2018-04-04
Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.
Product
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1198-2018·2018-04-04
GE Healthcare Recalls 28 Datex-Ohmeda TEC 7 Anesthesia Vaporizers
GE Healthcare is recalling 28 Datex-Ohmeda TEC 7 anesthesia vaporizers shipped from a service center without proper evaluation, potentially making them nonconforming.
Product
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
Category
Medical Device
Distribution
5 states
LowFDA (Devices)·Z-1242-2018·2018-04-04
Mindray Gas Module 3 monitoring spirometer recalled for regulatory changes
Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Product
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1179-2018·2018-04-04
Keystone Dental Recalls Mispackaged Plastic Abutment Sleeves
Keystone Dental Inc is recalling 55 units of plastic abutment sleeves that were packed as non-locking but are actually locking.
Product
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1122-2018·2018-03-28
MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.
Product
12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1127-2018·2018-03-28
MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk
Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.
Product
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1124-2018·2018-03-28
MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk
Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.
Product
12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1118-2018·2018-03-28
MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk
Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.
Product
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1100-2018·2018-03-28
Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage
Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.
Product
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography "…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1125-2018·2018-03-28
MedComp Two Part Adapter Recall for Potential Connection Failures
Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.
Product
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1139-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Product
BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI…
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-1133-2018·2018-03-28
Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect
Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.
Product
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1075-2018·2018-03-28
Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy
Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.
Product
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1141-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead in blood samples when used with certain assays.
Product
BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894)
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-0194-2018·2018-03-28
Monteris Medical Recalls NeuroBlate Systems Due to MRI Interaction
Monteris Medical Corp is recalling 52 NeuroBlate systems used for MRI-guided neurosurgery due to an unanticipated interaction with 1.5 Tesla MRI systems.
Product
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1123-2018·2018-03-28
MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures
Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.
Product
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1142-2018·2018-03-28
BD Vacutainer Tubes Recalled for Lead Test Inaccuracy
Becton Dickinson is recalling specific Vacutainer tubes because they may cause underestimation of lead levels in blood samples when used with certain assays.
Product
BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 367886 (UDI: 50382903678865); 4. 368040 (UDI: 50382903680400); 5. 366667 (UDI: 50382903666671); 6. 367880 (UDI: 50382903678803)
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-1119-2018·2018-03-28
MedComp Repair Kit Recalled for Potential Connection Failures
Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.
Product
REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Category
Medical Device
Distribution
Distributed nationwide

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