PlainRecalls

2016 Recalls

8,148 recalls · Page 146 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 recalls per day across the FDA, CPSC, and NHTSA 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 163 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 5 critical, 45 moderate, and 0 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Mar 2, 2016

Philips IntelliVue Measurement Module X1 Model: M3001A

Philips Electronics North America Corporation

FDA Devices Moderate Mar 2, 2016

Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bip…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Wel…

Bigwall Enterprises

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

HipLOC CHS Plate/Lag Screw Introducer

Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-0050-G14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gas…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Critical Mar 2, 2016

Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Pr…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Critical Mar 2, 2016

Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and …

Cook Inc.

FDA Devices Moderate Mar 2, 2016

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion …

Stryker Spine

FDA Devices Critical Mar 2, 2016

Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated c…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-0050-E16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-0050-616) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Philips IntelliVue Module Measurement X2 Model: M3002A

Philips Electronics North America Corporation

FDA Devices Moderate Mar 2, 2016

Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.

Stryker Howmedica Osteonics Corp.

FDA Devices Critical Mar 2, 2016

Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling …

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Mar 2, 2016

PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibri…

Cardiac Science Corporation

FDA Devices Moderate Mar 2, 2016

Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis

Fresenius Medical Care Renal Therapies Group, LLC

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemente…

Zimmer Biomet, Inc.

FDA Devices Critical Mar 2, 2016

Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-l…

Teleflex Medical

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Integrated Medical Systems 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 — consumer product and vehicle recall feeds for 2016