PlainRecalls

2016 Recalls

6,806 recalls · Page 17 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, 46 moderate, and 4 lower-severity recalls. The page references 13 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Devices Moderate Nov 23, 2016

Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Strai…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68 The Transpac Disposable Straig…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase ass…

Beckman Coulter Inc.

FDA Devices Moderate Nov 23, 2016

Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16 The Transpac D…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transducer (DSPT) i…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

ADVIA Centaur CA 19-9 Assay (250 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

CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL00372…

Trilliant Surgical Ltd.

FDA Devices Moderate Nov 23, 2016

MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravasc…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposable Strai…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight Pressure Tr…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposa…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

MEVION S250 Product Usage: Proton Radiation Therapy

Mevion Medical Systems, Inc.

FDA Devices Moderate Nov 23, 2016

Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Trans…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05 The Trans…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49 The Tran…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transdu…

ICU Medical, Inc.

FDA Devices Low Nov 23, 2016

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereo…

OMNI LIFE SCIENCE

FDA Devices Moderate Nov 23, 2016

CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transdu…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Low Nov 23, 2016

Dimension Vista IRON Flex reagent cartridges

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOU…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transducer (DSPT) is…

ICU Medical, Inc.

FDA Devices Low Nov 23, 2016

Brilliance iCT Computed Tomography X-ray system, Model 728306

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure trans…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or medias…

Atrium Medical Corporation

FDA Devices Moderate Nov 23, 2016

BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

C.R. Bard, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extra…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-…

Alphatec Spine, Inc.

FDA Devices Moderate Nov 23, 2016

SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Nov 23, 2016

Trifurcated Monitoring Kit w/84" Safeset" Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55 The Transpac Disposable Straig…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communi…

Merge Healthcare, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transdu…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an …

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavit…

Atrium Medical Corporation

FDA Devices Low Nov 23, 2016

Dimension IRON Flex reagent cartridges

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 23, 2016

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

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 23, 2016

TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item…

ICU Medical, Inc.

FDA Devices Moderate Nov 23, 2016

Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 …

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