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

28526–28550 of 40325

ModerateFDA (Devices)·Z-0388-2017·2016-11-16
Akita Sumitomo Bakelite Recalls Mislabeled Sterile Electrosurgical Knives
Akita Sumitomo Bakelite Co., Ltd. is recalling 15 units of sterile electrosurgical knives that were mislabeled as Standard type instead of Jr type-Long.
Product
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0393-2017·2016-11-16
Baylis Medical Recalls NRG Transseptal Needles Due to Packaging Defect
Baylis Medical Corp is voluntarily recalling NRG Transseptal Needles and RF Kits because the Tyvek packaging pouches may have integrity defects.
Product
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0368-2017·2016-11-16
Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects
Zimmer Biomet Surgical is recalling Air Dermatome II Handpiece loaners because the surface coating may blister, peel, or discolor over time. No injuries have been reported.
Product
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0363-2017·2016-11-16
C.R. Bard Recalls X-Force Nephrostomy Balloon Dilation Catheter Kits
C.R. Bard is recalling 192 units of X-Force Nephrostomy Balloon Dilation Catheter Kits because a contract manufacturer packaged an incorrect 30Fr sheath instead of the labeled 24Fr sheath.
Product
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0366-2017·2016-11-16
FDA Recalls Custom Packaging for Devon Light Gloves
The FDA is recalling custom packaging for Devon Light Gloves due to added instructions for use regarding barrier integrity inspection.
Product
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0365-2017·2016-11-16
FDA Recalls Covidien Devon Light Glove Sub-Assembly for Added Instructions
The FDA is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly to add instructions for use regarding barrier integrity inspection.
Product
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0379-2017·2016-11-16
Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference
Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.
Product
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0364-2017·2016-11-16
FDA Adds Instructions for Use to Covidien Devon Light Glove Recall
The FDA is adding instructions to inspect the barrier integrity of the Covidien Devon Light Glove after application. This affects sterile surgical kits distributed in the US and abroad.
Product
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0372-2017·2016-11-16
Schaerer Surgical Table Floor Locking Cylinders Recalled for Leak Risk
Schaerer Medical USA Inc is recalling replacement floor locking cylinders for model 7300 surgical tables because they may leak due to an incorrect O-ring.
Product
Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0380-2017·2016-11-16
Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Mislabeled French Size
Stryker Sustainability Solutions is recalling four reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters because they may be mislabeled for French size during reprocessing.
Product
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0369-2017·2016-11-16
Medimaps TBS iNsight Software Recalled for Incorrect FRAX Calculations
Medimaps Group is recalling TBS iNsight v.3.0.1 software because FRAX values are incorrect when specific spine scan conditions are met.
Product
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0371-2017·2016-11-16
Schaerer 7300 Surgical Tables Recalled for Defective Floor Locking Cylinders
Schaerer Medical USA Inc is recalling four 7300 model surgical tables because defective floor locking cylinders may leak due to incorrect O-rings.
Product
The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0326-2017·2016-11-09
Hill-Rom Recalls Ceiling Brackets Due to Potential Fall Hazard
Hill-Rom is recalling 188 ceiling brackets with a larger center hole that could cause the system to fall if the safe working load is exceeded.
Product
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0325-2017·2016-11-09
FDA Recalls Encore Medical Empowr PS Knee System Box Cut Guides
Encore Medical is recalling 436 units of the Empowr PS Knee System Box Cut Guide because the design can cause femoral chipping during surgery.
Product
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0357-2017·2016-11-09
Unomedical AC TenderLink Insulin Infusion Tubing Recalled for Detachment Risk
Unomedical As is recalling AC TenderLink insulin infusion tubing sets due to a risk of tubing detachment. The voluntary recall affects 653,280 units distributed in the US and internationally.
Product
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0349-2017·2016-11-09
Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk
Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.
Product
Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0337-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.
Product
Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0336-2017·2016-11-09
Stryker Neurovascular Recalls Guider Softip XF Guide Catheters
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0342-2017·2016-11-09
Stryker Neurovascular Recalls Guider Softip XF Guide Catheters
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0352-2017·2016-11-09
Medline Recalls Rigid Suction Canisters Due to Implosion Risk
Medline Industries is recalling 7,680 Rigid Suction Canisters (2000 CC and 3000 CC) because they may implode when subjected to excessive negative pressure.
Product
Rigid Suction Canister 3000 CC and 2000 CC.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0358-2017·2016-11-09
Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment
Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.
Product
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0333-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks.
Product
Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0322-2017·2016-11-09
Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction
Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.
Product
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0330-2017·2016-11-09
Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures
Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, due to out-of-specification microbiological test results.
Product
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2017·2016-11-09
Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure
Hospira is recalling Symbiq Two Channel Infusers due to a backup battery failure caused by incorrect component installation on some power supply boards.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Category
Medical Device
Distribution
Distributed nationwide

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