Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 65mm Item # 195270 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 71mm Item # 195273 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 75 mm Item # 195757 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 69 mm Item # 195248 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 67 mm Item # 195753 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, S... | The reported stress crack in the port of the swivel elbow where the flip cap is inserted could re... | Class II | Bioseal Corporation |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 63mm Item # 195269 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 65 mm Item # 195246 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 t... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 69 mm Item # 195754 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, R... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 83 mm Item # 195277 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 67 mm Item # 195247 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 79 mm Item # 195252 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 91 mm Item # 195279 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 73 mm Item # 195756 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Materia... | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 83 mm Item # 195759 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnos... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Vanguard XP Tibial Tray 73 mm Item # 195250 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | QuickGraft¿ Model # 430PST | Measurement listed on the label is not taken under tension, and this would cause possible extensi... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 87 mm Item # 195278 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 75mm Item # 195275 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 63 mm Item # 195245 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 59 mm Item # 195750 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material... | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 75 mm Item # 195251 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use,... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 65 mm Item # 195752 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 79 mm Item # 195758 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Remisol Advance running on hardware with Windows XP, Windows 7, Windows Serve... | A patch was released for a critical remote code execution vulnerability in remote desktop service... | Class II | Normand-Info S.A.S.U. |
| Aug 14, 2019 | Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A | Due to manufacturing processing error, wrench causing stripping when torqueing nuts. | Class II | New Standard Device Inc |
| Aug 14, 2019 | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40... | The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended ... | Class II | Bard Peripheral Vascular Inc |
| Aug 14, 2019 | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100... | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitig... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 14, 2019 | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Pr... | The deficit displayed by the pump can differ from the real deficit, leading potentially to patien... | Class II | WOM World of Medicine AG |
| Aug 13, 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100... | Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. | Class III | Baxter Healthcare Corporation |
| Aug 13, 2019 | STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B... | The product does not meet certain internal strength testing specifications. | Class II | Ethicon, Inc. |
| Aug 13, 2019 | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the ... | AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an A... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 13, 2019 | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1... | Firm identified a subset of its generators that were sterilized one additional sterilization cycl... | Class II | LivaNova USA Inc |
| Aug 13, 2019 | STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B4... | The product does not meet certain internal strength testing specifications. | Class II | Ethicon, Inc. |
| Aug 12, 2019 | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 12... | After a recent upgrade to the collimator software version 8.5, the firm became aware that the mul... | Class II | Varian Medical Systems, Inc. |
| Aug 12, 2019 | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage... | FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B1... | Class II | Zeus Scientific, Inc. |
| Aug 9, 2019 | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components direct... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... | Class I | Medtronic Navigation, Inc. |
| Aug 9, 2019 | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components ... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | Class II | Nobel Biocare Usa Llc |
| Aug 9, 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.