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

31476–31500 of 40325

LowFDA (Devices)·Z-0322-2016·2015-12-02
Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling
Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.
Product
Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds…
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0328-2016·2015-12-02
Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies
Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.
Product
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0323-2016·2015-12-02
Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert
Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.
Product
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-0274-2016·2015-11-25
Hill-Rom Recalls 100 Low Bed Units Due to Patient Injury Reports
Hill-Rom is voluntarily recalling 12,251 Hill-Rom 100 Low Beds because patients were injured while exiting the beds at the lowest position setting.
Product
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0230-2016·2015-11-25
Event Medical Recalls Inspiration Ventilators Due to Power Board Failure
Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.
Product
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0277-2016·2015-11-25
Teleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
Teleflex Medical is recalling 2,050 Taut Intraducers 10/BX7.5 FR 3.5 devices because a defective component can cause gas leakage, potentially requiring device replacement.
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0284-2016·2015-11-25
Prism Medical C-300 Ceiling Lifts Recalled for Drive Shaft Failure
FDA is recalling 561 Prism Medical C-300 ceiling lifts because the drive shaft and over-speed arm may fail simultaneously, potentially causing a patient to fall.
Product
Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0295-2016·2015-11-25
Fresenius 132 Gallon Dry Acid Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 348 dry acid dissolution units because defective motors may generate smoke or cause fire.
Product
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2016·2015-11-25
Fresenius GranuFlo Dissolution Units Recalled for Fire Risk
Fresenius Medical Care is recalling 918 GranuFlo Dissolution Units because they lack full thermal protection, which can generate smoke or lead to fire.
Product
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0285-2016·2015-11-25
Prism Medical P-300 Portable Consumer Lift Recalled for Drive Shaft Failure
ErgoSafe Products is recalling 1,721 Prism Medical P-300 Portable Consumer Lifts because the drive shaft and over speed arm may fail, potentially causing a patient to fall.
Product
Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0296-2016·2015-11-25
Fresenius Modified Mixer Motor Recalled Due to Fire Risk
Fresenius Medical Care is recalling 992 Modified Mixer Motors for 132 Gallon Dissolution Units because they lack full thermal protection, posing a fire hazard.
Product
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0282-2016·2015-11-25
Brainlab IGS System Recalled for Inaccurate Patient Anatomy Registration
Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.
Product
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0280-2016·2015-11-25
Cyberonics Vagus Nerve Stimulator Recall for Sensing Delays
Cyberonics is recalling 27 Model 106 Vagus Nerve Stimulator generators due to delays in heartbeat detection and potential decreased battery longevity.
Product
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0310-2016·2015-11-25
Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity
Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
Product
EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0287-2016·2015-11-25
Civco Needle Guide Starter Kit Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling 508 boxes of Needle Guide Starter Kits because the sterility of the product cannot be assured.
Product
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2016·2015-11-25
Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests
Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.
Product
DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0301-2016·2015-11-25
Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity
Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and Australia.
Product
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0289-2016·2015-11-25
Civco PercuNav Tracking Bracket Recalled Due to Sterility Concerns
Civco Medical Instruments is recalling PercuNav tracking bracket kits because the sterility of the product cannot be assured.
Product
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0276-2016·2015-11-25
Synthes Sternal ZIPFIX Application Instrument Recall for Screw Failure Risk
Synthes is recalling 267 previously repaired Sternal ZIPFIX Application Instruments because the screws may break or loosen.
Product
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0313-2016·2015-11-25
Ameditech Recalls Micro Screen 6 Panel Drug Abuse Test Cups
Ameditech is recalling Micro Screen 6 Panel Cup drug abuse tests because they have shown reduced reactivity.
Product
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0273-2016·2015-11-25
Philips ECG Sync Cables Recalled for Electrical Interference Risk
Philips is recalling ECG sync cables used with HeartStart monitors because electrical interference can cause misinterpretation of heart signals or interrupt pacing.
Product
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0281-2016·2015-11-25
Stryker Recalls PCA Acetabular Inserts Due to Regulatory Omission
Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.
Product
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0272-2016·2015-11-25
Precision Medical Recalls Easy Dial Oxygen Regulators Due to Label Error
Precision Medical is recalling 315 Easy Dial Oxygen Regulators because the settings label may be off by one position, causing incorrect oxygen flow.
Product
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0292-2016·2015-11-25
Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure
Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.
Product
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0290-2016·2015-11-25
Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides
Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.
Product
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Category
Medical Device
Distribution
Distributed nationwide

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31476–31500 of 40325