PlainRecalls

2023 Recall Year Insight

Federal agencies issued 6,706 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.42% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 18.4 recalls per day across the FDA, CPSC, USDA FSIS, 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 135 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 2023.

On this page of 50 records, severity classification shows 2 critical, 48 moderate, and 0 lower-severity recalls. The page references 15 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 2023 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6

Medtronic Inc

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflatio

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

Convergent Dental

FDA Devices Moderate Nov 29, 2023

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Nov 29, 2023

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

Musculoskeletal Transplant Foundation, Inc.

FDA Devices Moderate Nov 29, 2023

SmartPath to dStream for 1.5T

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.

Becton Dickinson & Company

FDA Devices Moderate Nov 29, 2023

Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

IRON assay, Reference Numbers 6K95-41 and 6K95-30

Sentinel CH SpA

FDA Devices Moderate Nov 29, 2023

Ingenia 1.5T CX

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F,

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

LEONI CIA CABLE SYSTEMS

FDA Devices Moderate Nov 29, 2023

Achieva 1.5T

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND

Becton Dickinson & Company

FDA Devices Moderate Nov 29, 2023

Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; 3. Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105H

SunMed Holdings, LLC

FDA Devices Moderate Nov 29, 2023

Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Achieva 1.5T Initial System

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Ba

SunMed Holdings, LLC

FDA Devices Critical Nov 29, 2023

VariSoft infusion set, Model Number 1002827

Unomedical A/S

FDA Devices Moderate Nov 29, 2023

Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Achieva 1.5T Conversion

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

LEONI CIA CABLE SYSTEMS

FDA Devices Moderate Nov 29, 2023

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010454; BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #

Becton Dickinson & Company

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.

Aizu Olympus Co., Ltd.

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Intera 1.5T Power/Pulsar

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

Intera 1.5T

Philips North America Llc

FDA Devices Moderate Nov 29, 2023

FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORC

BioFire Diagnostics, LLC

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560

Biomet, Inc.

FDA Devices Critical Nov 29, 2023

VariSoft infusion set, Model Number 1002830

Unomedical A/S

FDA Devices Moderate Nov 29, 2023

Alinity c Iron Reagent, Reference Number 08P3920

Sentinel CH SpA

FDA Devices Moderate Nov 29, 2023

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

Instrumentation Laboratory

FDA Devices Moderate Nov 29, 2023

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Medtronic Neuromodulation

FDA Devices Moderate Nov 29, 2023

Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414

Biomet, Inc.

FDA Devices Moderate Nov 29, 2023

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.

SunMed Holdings, LLC

Nearby Recall Years

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

Compare 2023 with 2022 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2023

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2023 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.