Browse Device Recalls
2,888 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,888 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 2,888 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 24, 2024 | TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... | Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter ... | Class II | B. Braun Medical, Inc. |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... | Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter... | Class II | B. Braun Medical, Inc. |
| Jan 16, 2024 | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedure... | Japanese IFU version had slightly different language and illustrations from the English IFU, whic... | Class II | Olympus Corporation of the Americas |
| Jan 16, 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use... | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190TL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190I. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-HQ190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-H180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number CF-Q180AL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190DL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 9, 2024 | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparo... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 9, 2024 | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... | The sterile blister packaging may be damaged, and sterility may be compromised. | Class II | Aesculap Inc |
| Jan 5, 2024 | Hemostasis Probe, Model: CD-B622LA | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... | Class II | Olympus Corporation of the Americas |
| Dec 29, 2023 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm)... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 29, 2023 | MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC M... | Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed a... | Class II | Aesculap Inc |
| Dec 15, 2023 | ESG PK CUTTING FORCEPS, 5MM, 33CM | The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or duri... | Class II | Olympus Corporation of the Americas |
| Dec 15, 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... | Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... | Class II | Globus Medical, Inc. |
| Dec 11, 2023 | Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, pre... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... | Class II | Globus Medical, Inc. |
| Dec 11, 2023 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prep... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... | Class II | Globus Medical, Inc. |
| Dec 11, 2023 | Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, a... | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have... | Class II | Globus Medical, Inc. |
| Dec 11, 2023 | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilat... | The expiration date is missing from the primary (inner) packaging. The secondary (outer) box labe... | Class II | Olympus Corporation of the Americas |
| Dec 8, 2023 | Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope ... | Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result ... | Class II | Olympus Corporation of the Americas |
| Dec 7, 2023 | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGP... | Class I | Globus Medical, Inc. |
| Dec 5, 2023 | Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultras... | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Oakworks Inc |
| Dec 5, 2023 | Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Ec... | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Oakworks Inc |
| Dec 5, 2023 | Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Ec... | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Oakworks Inc |
| Dec 5, 2023 | Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echoca... | Backrest platform stress fracture - the table is not operational in an inclined position | Class II | Oakworks Inc |
| Dec 4, 2023 | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympu... | Class II | Olympus Corporation of the Americas |
| Dec 4, 2023 | SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch se... | Class II | Olympus Corporation of the Americas |
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.