Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 10, 2022 | Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... | Product contains incorrect chemical indicators in packaging. | Class III | Steris Corporation Hopkins Facility |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jul 12, 2022 | AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... | The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... | Class III | Siemens Medical Solutions USA, Inc |
| Jun 28, 2022 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Aniara Diagnostica LLC |
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... | Class III | Zeiss, Carl Inc |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... | Class III | R & D Systems, Inc. |
| Jun 10, 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... | Class III | Invacare Corporation |
| Jun 9, 2022 | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| Jun 9, 2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| May 31, 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not matc... | Class III | Boston Scientific Corporation |
| May 31, 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... | Firm has revised labeling to consistently call out storage conditions and revised the instruction... | Class III | Synapse Biomedical Inc |
| May 25, 2022 | a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABS... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catal... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gra... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethyle... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Imp... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARK... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack St... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8"... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 131... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS)... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Co... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 20, 2022 | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... | Label provided for substrate vail contained incorrect expiration date. | Class III | Agilent Technologies, Inc. |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx ... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 13, 2022 | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , R... | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications | Class III | Volcano Corp |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Microbiologics Inc |
| Apr 14, 2022 | putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY | Patient chart label contains incorrect Part Number and volume amount. | Class III | Cerapedics, Inc. |
| Mar 25, 2022 | CK MB Calibrator, Catalogue Number CK2393 | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... | Class III | Randox Laboratories Ltd. |
| Feb 24, 2022 | Regard Custom Procedure Kits containing BD Luer Lok Access Devices | Recalled devices were packaged in convenience kits. | Class III | ROi CPS LLC |
| Feb 16, 2022 | Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 1... | IRISpec CA failures for glucose. | Class III | Beckman Coulter, Inc. |
| Feb 14, 2022 | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... | Class III | Cook Medical Incorporated |
| Feb 14, 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... | Class III | Cytocell Ltd. |
| Feb 14, 2022 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... | Class III | Cook Medical Incorporated |
| Feb 4, 2022 | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... | May show unexpected locus specific signals in addition to those at 14q32. | Class III | Cytocell Ltd. |
| Feb 3, 2022 | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Nu... | Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or be... | Class III | Volcano Corp |
| 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 13, 2022 | HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad... | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. | Class III | Physio-Control, Inc. |
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.