Browse Device Recalls
86 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 86 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 86 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 21, 2022 | Medline CHEST TUBE REORDER NO: DYNJ36762A | Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... | Class II | Medline Industries Inc. |
| 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 |
| 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 |
| Sep 14, 2020 | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... | 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 #650304917, MTO Protection Station Plus with Drape - Product Usage:... | 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 #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... | 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 #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... | 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 #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... | 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 #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... | Class II | Medline Industries Inc |
| Sep 1, 2020 | ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... | There have been reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Aug 12, 2020 | Central Line Dressing Change Tray | Potential of incomplete seals impacting the sterility of the kit. | Class II | Medline Industries Inc |
| Jul 28, 2020 | Control, Calibrator Verified, Triage BNP, Model ALR88755 | Product was shipped with refrigeration (ice) instead of frozen (dry ice). | Class II | Medline Industries Inc |
| Jul 9, 2020 | Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... | Potential risk of brush detachment during cleaning. | Class II | Medline Industries Inc |
| Jun 30, 2020 | ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Jun 30, 2020 | ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... | There are reports of the suction catheter coming apart from the device assembly during use. | Class II | Medline Industries Inc |
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging seal and loss of ster... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Jan 21, 2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 21, 2020 | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI... | The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz... | Class II | Medline Industries Inc |
| Jan 7, 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... | There is potential for the sterile wrap to become loose while in transit and compromise the steri... | Class II | Medline Industries Inc |
| Oct 30, 2019 | Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A | The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... | Class II | Medline Industries Inc |
| Sep 18, 2019 | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... | Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. | Class II | Medline Industries Inc |
| Sep 6, 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... | The recall is being conducted due to a potential defective component on the circuit board causing... | Class II | Medline Industries Inc |
| Aug 9, 2019 | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... | Samples in the identified lot were found to have incomplete or open packaging seals. | 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.