Browse Device Recalls
1,303 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,303 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 1,303 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2022 | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B,... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| May 25, 2022 | MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Cath... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3 | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover M... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 11, 2022 | Medline Pill Splitters; 1 each/box; 144 boxes/carton | Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 9, 2022 | Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box | The mask cuff may disconnect from the device's breathing tube. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8... | Product was improperly store which may cause a delay in results. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 8, 2022 | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes conta... | The product was stored incorrectly due to improper storage controls which may lead to delayed res... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 4, 2022 | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride In... | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 25, 2022 | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit... | The product was incorrectly shipped at room temperature rather than refrigerated. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 29, 2021 | MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes | Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 | Michels Transport Medium, 20ML Prefilled Cont | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Premier Rotaclone, Rx only | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | Product stored incorrectly in temperature controlled setting instead of refrigeration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 30, 2021 | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 | Affected product was shipped from the warehouse at room temperature instead of the required refri... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 27, 2021 | Neuro Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Bedside PICC CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Major Vascular CDS Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | Venous Access Pack-LF Convenience Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 27, 2021 | EVLP Convenience Pack/Kit | NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Class II | Medline Industries Inc |
| Oct 22, 2021 | ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954 | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrige... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 6, 2021 | NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF ... | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... | Class II | Medline Industries Inc |
| Aug 6, 2021 | NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H... | Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, c... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired com... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing e... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| Jul 1, 2021 | Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expire... | The kits may contain an expired component. | Class II | Medline Industries Inc |
| May 25, 2021 | Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Lar... | Potential for mold contamination (Aspergillus vadensis) | Class II | Medline Industries Inc |
| Apr 30, 2021 | Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... | The devices may not meet the minimum required sterility assurance level. | Class II | Medline Industries Inc |
| Mar 15, 2021 | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the... | Possible false negative or false positive results due to the product being compromised during shi... | Class II | Medline Industries Inc |
| Jan 25, 2021 | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: mon... | Product was compromised during shipment. | Class II | Medline Industries Inc |
| Jan 15, 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... | Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... | Class III | Medline Industries Inc |
| Nov 13, 2020 | Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 13, 2020 | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... | The cylindrical sponge component is not x-ray detectable. | Class II | Medline Industries Inc |
| Nov 5, 2020 | RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin... | RevMedX Trauma Dressing is being recalled due to package seal integrity. | Class II | Medline Industries Inc |
| Oct 1, 2020 | The Quidel Triage BNP Calibrators | Product compromised during shipment. | Class II | Medline Industries Inc |
| Sep 15, 2020 | Quick Release Gait Belt, 60 | The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 14, 2020 | Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries 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.