PlainRecalls

2016 Recalls

6,806 recalls · Page 16 of 137

2016 Recall Year Insight

Federal agencies issued 6,806 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.11% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.6 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 137 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2016.

On this page of 50 records, severity classification shows 0 critical, 47 moderate, and 3 lower-severity recalls. The page references 12 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (45), FDA Drug (5), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2016 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Nov 23, 2016

L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 6…

Sandoz Inc

FDA Drug Moderate Nov 23, 2016

L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (N…

Sandoz Inc

FDA Drug Low Nov 23, 2016

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) ,…

Amerisource Health Services

FDA Drug Low Nov 23, 2016

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03

CutisPharma, Inc.

FDA Drug Low Nov 23, 2016

FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05

CutisPharma, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

C.R. Bard, Inc.

FDA Devices Moderate Nov 23, 2016

The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and …

Sorin Group USA, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80 The Transpac Dispo…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handli…

Inpeco S.A.

FDA Devices Moderate Nov 23, 2016

TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSP…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE M…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05 The Transpac Disposable Str…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45 The Transpac Disposable Straight Pressure T…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Stra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravas…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cros…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 23, 2016

TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The Transpac Disposable Straight Pressure Tra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straig…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05 The Transpac Disposable S…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravas…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05 The Transpac Disposable S…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 23, 2016

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Healthcare, Inc.

FDA Devices Moderate Nov 23, 2016

PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure T…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND RED PLUGS, Item No. 46104-10 The Transpac Disposable Str…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Sie…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Trans…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MEVION S250 Product Usage: Proton Radiation Therapy System

Mevion Medical Systems, Inc.

FDA Devices Moderate Nov 23, 2016

Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Transducer (D…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77 The Transpac Di…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transducer (DSP…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05 The Transpac Dispos…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60", DISPOSABLE TRANSDUCER WITH BONDED STOPCOC…

ICU Medical, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2016 with 2015 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2016