Device recall: STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Class II FDA enforcement event 91124. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Stradis Medical, LLC dba Stradis Healthcare started this device recall on 2 Nov 2022. The firm address in the FDA record is in Peachtree Corners, GA. FDA put the recall in Class II. FDA event 91124 has 78 product records. The first FDA enforcement report date is 21 Dec 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US nationwide distribution, and Canada.
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
78 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0481-2023 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | 80 kits | Class II | Ongoing | 21 Dec 2022 |
| Z-0482-2023 | ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray | 10 kits | Class II | Ongoing | 21 Dec 2022 |
| Z-0483-2023 | STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS | 25 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0484-2023 | BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray | 80 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0485-2023 | STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental | 12 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0486-2023 | STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray | 18 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0487-2023 | STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray | 6 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0488-2023 | STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray | 20 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0489-2023 | STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental | 6 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0490-2023 | STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray | 18 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0491-2023 | STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray | 6 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0492-2023 | Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray | 180 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0493-2023 | STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray | 30 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0494-2023 | Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray | 162 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0495-2023 | STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS, | 20 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0496-2023 | STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental | 12 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0497-2023 | Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP | 20 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0498-2023 | STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010, | 100 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0499-2023 | STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001 | 100 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0500-2023 | STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular | 180 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0501-2023 | STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray | 150 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0502-2023 | HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611 | 10 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0503-2023 | HENRY SCHEIN, Vein Clinics 1, Item No.570-1426 | 800 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0504-2023 | HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray | 15 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0505-2023 | HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 | 20 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0506-2023 | HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray | 35 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0507-2023 | HENRY SCHEIN, Basin Pack, Item No.570-1692 | 30 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0508-2023 | HENRY SCHEIN, Basin Set, Item No.570-1803 | 96 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0509-2023 | HENRY SCHEIN, BREAST PACK, Item No.570-2397 | 8 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0510-2023 | HENRY SCHEIN, GYN PACK, Item No.570-2625 | 20 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0511-2023 | HENRY SCHEIN, ENT PACK, Item No.570-2718 | 104 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0512-2023 | HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505 | 24 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0513-2023 | HENRY SCHEIN, VEIN TRAY, Item No.570-2738, | 18 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0514-2023 | HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742 | 12 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0515-2023 | HENRY SCHEIN, OMFS, Item No.570-2779, | 90 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0516-2023 | HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, | 5 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0517-2023 | HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 | 675 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0518-2023 | HENRY SCHEIN, CATH PACK Item No.570-2789 | 100 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0519-2023 | HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 | 18 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0520-2023 | HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883 | 24 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0521-2023 | HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 | 25 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0522-2023 | HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 | 144 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0523-2023 | HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900, | 10 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0524-2023 | HENRY SCHEIN, Knee Pack, Item No.570-2908, | 48 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0525-2023 | HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930 | 16 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0526-2023 | HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 | 144 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0527-2023 | HENRY SCHEIN, Amnio Tray, Item No.570-3059, | 510 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0528-2023 | HENRY SCHEIN, RHINO PACK, Item No.570-3070 | 328 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0529-2023 | HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072 | 27 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0530-2023 | HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 | 80 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0531-2023 | HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091, | 72 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0532-2023 | HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092 | 581 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0533-2023 | HENRY SCHEIN, Labiaplasty PackItem No.570-3118, | 42 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0534-2023 | HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131 | 140 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0535-2023 | STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, | 300 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0536-2023 | STRADIS HEALTHCARE, Lipo, Item No.681-254, | 6 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0537-2023 | STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, | 15 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0538-2023 | STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228, | 5 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0539-2023 | STRADIS HEALTHCARE, Ablation Pack, Item No.682-130, | 40 units | Class II | Ongoing | 21 Dec 2022 |
| Z-0540-2023 | STRADIS HEALTHCARE, Phleb, Item No.682-1425, | 20 units | Class II | Ongoing | 21 Dec 2022 |
The table shows 60 of 78 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 78Median of the firm: 5
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jul 2022 | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 | Device | Class II | 3 |
| 25 Feb 2022 | Surgicare Neuro Pack - Neurological Kit | Device | Class II | 5 |
| 28 Oct 2021 | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk | Device | Class II | 1 |
| 10 Sep 2021 | Tenaculum, Plastic | Device | Class II | 6 |
Official channels
- FDA enforcement report Z-0481-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 91124. https://recallregister.com/fda/ii/91124/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US nationwide distribution, and Canada.
- What quantity of product is in FDA event 91124?
- The event has 78 product records. The first record gives this quantity:
80 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.