Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 9, 2022 | The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram... | Product was labelled with the incorrect manufacturing and distribution dates. | Class II | Wright Medical Technology, Inc. |
| Feb 9, 2022 | Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ... | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma... | Class II | Maquet Cardiovascular, LLC |
| Feb 7, 2022 | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... | Units not properly inspected prior to release to the market, may not function as indicated in the... | Class II | B Braun Medical Inc |
| Feb 1, 2022 | (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped... | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packa... | Class II | BSN Medical Inc |
| Jan 27, 2022 | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... | Class II | Medtronic MiniMed |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-ca... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 24, 2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as ... | Class III | Volcano Corp |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 21, 2022 | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, ... | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | Class II | Stryker Sustainability Solutions |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... | A risk for product contamination was identified for the affected product lot. If used, there is a... | Class II | NeuMoDx Molecular Inc |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 20, 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 20, 2022 | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 18, 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | Class II | Merete Medical GmbH |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... | individual components have been labelled with incorrect colours. The red and green colours are op... | Class II | Cytocell Ltd. |
| Jan 14, 2022 | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6... | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ... | Class II | Maquet Cardiovascular, LLC |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 13, 2022 | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | Products are mislabeled with the incorrect product identification on individual kit labeling. | Class II | ROi CPS LLC |
| Jan 6, 2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 6, 2022 | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised... | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch la... | Class II | BALT USA, LLC |
| Dec 30, 2021 | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 30, 2021 | Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 29, 2021 | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ... | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind... | Class II | Young Dental Mfg Co I LLC |
| Dec 28, 2021 | Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin... | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ... | Class II | Hobbs Medical, Inc. |
| Dec 23, 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) | Class II | Olympus Corporation of the Americas |
| Dec 15, 2021 | CURAD REUSABLE GEL HOT/COLD PACK | The product contains natural rubber latex but the label states that it does not. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... | The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... | Class II | CELLTRION USA INC |
| Dec 1, 2021 | Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated... | Class II | Maquet Cardiovascular, LLC |
| Nov 30, 2021 | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual... | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental impl... | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Regard, T AND A - Rogers, sterilized convenience kits | Kits lacks rubber latex warning label. | Class II | ROi CPS LLC |
| Nov 29, 2021 | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Heel Snuggler, Reference # 989805603411 99047 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 26, 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 24, 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF ... | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orie... | Class II | Reflexion Medical, Inc. |
| Nov 22, 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | This recall has been initiated to provide a labeling update with revised instruction how to opera... | Class II | Gentherm Medical, LLC |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 11, 2021 | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Ins... | Due to product label/labeling being altered from it's approved state. | Class II | Orchestrate Orthodontic Technologies, Inc. |
| Nov 10, 2021 | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... | The dosage information on the pouch is incorrect; the primary carton label is correct. | Class III | Tapemark Company |
| Nov 9, 2021 | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... | Class II | Medtronic Navigation, Inc. |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
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.